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Nuvasive reline pedicle screw system. NuVasive implants and instrumentation systems.


Nuvasive reline pedicle screw system The external tulip engagement features percutaneous pedicle screws from T8 to S1 bilaterally (11 on each side) in 12 non-pathologic cadaver specimens. 0 Reline System (K170126), e SpheRx II. , San Diego, CA, USA). Suit roun loor aspia ouse h aterfront, lstree ert D6 B K Pedicle screws and rods Postsurgical view Two-level lumbar XLIF with pedicle screw and rod fixation Single-level lumbar XLIF with plate. Classification Name: Thoracolumbosacral Pedicle Screw System, Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation Orthosis . 5 mm from the distal tip on all screw sizes About NuVasive NuVasive, Inc. Reline Small Stature adds strength without sacrificing size, NuVasive Reline System. Braly performed a Lateral ALIF with percutaneous screws while minimizing radiation throughout the case with LessRay. 3050, 888. Read their interview below: What sparked the need for RELINE MAS Midline? Tyler & Hayden, Engineering: RMM was driven by market analysis, mainly the opportunity to broaden the RELINE portfolio Continued implant is equivalent to unilateral pedicle screws in lat - eral bending and axial rotation motion planes. A pedicle screw Offered in cannulated and non-cannulated options All screw sizes feature six fenestrations (three through holes) spaced 120° apart First fenestration is 5. , Precept Spinal System, Armada Spinal System and Reline System. 5-5. Device Description The NuVasive Reline 4. 5mm, and 6. The . CD Horizon Spinal System from Medtronic. AccessGUDID - ReLine (00887517948731)- RELINE MAS Pusher, Fenestrated. The implanted Screw implanted on (b)(6) 2022 and found on follow up not seated on shank, surgeon stated may not have fully seated tulip on shank. 0 System. G. and . Reline 3D, which is an extension to the NuVasive’s Reline system, is part of the firm’s comprehensive spine fixation portfolio that includes Reline Open, Reline MAS, Reline Trauma and Reline Small Stature. The procedure is designed to benefit surgeons and patients by providing intraoperative flexibility Guided by NVM5 and LessRay, he implanted Modulus XLIF with Osteocel Pro and XFixation with Reline MAS Reduction pedicle screws, providing segmental stabilization and indirect decompression. Reline is the most comprehensive fixation system in spine, offering an easy-to-use yet powerful solution. Dr. Clinical benefits Posterior xK140178 – MAGEC Spinal Bracing And Distraction System D. NuVasive has designed EOS treatments that work together, with a child's size in mind. COM 16-NUVA-1444. 5x45mm 2FC PolyaxialGlobal Medical Device Nomenclature (GMDN) Intraoperative image in the lateral position and fluoroscopic imaging. Implant components are available in a variety sizes and can The NuVasive Reline System is a pedicle screw system that consists of a variety of screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors and associated general instruments. Additionally the NuVasive Reline System is When used as a pedicle screw fixation system, the NuVasive Reline System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an When used for posterior non-cervical screw fixation in pediatric patients, NuVasive Reline System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. com If you would like to learn more about patient support and education for chronic back, leg, Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e. Implant components are available in a variety sizes and can Early-onset scoliosis (EOS) solutions. FDA Premarket Submission Thoracolumbosacral Pedicle Screw System: 510(k) Number NuVasive Reline System: Applicant: NuVasive, Incorporated: 7475 Lusk Boulevard: San Diego, CA 92121 Applicant Contact: Joseph De La Rosa: Correspondent: NuVasive, Incorporated: 7475 Lusk Boulevard: San Diego, CA 92121 Correspondent Contact Reimbursement We’re dedicated to offering resources for healthcare professionals seeking a better understanding of coding, coverage, and payment related to our technologies and therapies. The Reline® MAS® pedicle screw system (NuVasive, Inc. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e. 7475 Lusk Boulevard, San Diego, CA 92121. This results in reduced surgical times, minimal blood loss, a shorter hospital stay Vendor/Manufacturer: NuVasive®Product/Product Line: RELINE® Posterior Fixation System Vendor/Manufacturer Catalog #: 11355070Global Unique Device (GUD) Primary Device Identifier Number: 00887517505064Global Unique Device (GUD) Device Description: RELINE MAS Ti Rod, 5. a ieg 212 S hone 800-475-913 ax 800-475-9134 NuVasive U td. connected to the ® SpheRx. WWW. The Brigade Lateral System (lordotic The surgical plan included two Cohere TLIF-O interbodies with Osteocel Pro from L3-L5, and Reline Traction screws to fixate the construct. Toll Free . Hours: 8:00 a. I-PAS III (Insulated Pedicle Access III) is a Jamshidi needle with integrated NVM5 which enables proactive stimulated EMG monitoring, which helps the surgeon to accurately, reproducibly, and efficiently place pedicle screws, especially in minimally invasive techniques. April 26–28 in Nashville, NuVasive will feature its Model: NuVasive Modulus Interbody System Anatomy of Spine: The human spine is made up of 24 bones or vertebrae in the cervical (neck) spine, thoracic (chest) spine and lumbar (lower back) spine plus the sacral bones. Technological Characteristics. 0713 or reimbursement@nuvasive. The system’s 5. Classification: 21 CFR § 888. 5x45mm 2S Polyaxial. , San Diego, CA, USA), while the rest of the The system, when combined with NuVasive access and interbody technologies, is designed to provide a minimally invasive approach to bilateral decompression under complete visualization, interbody United States Customer Care Team. , San Diego, ervical screw fixation in pediatric patients, NuVasive Reline System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Device Description The NuVasive Reline Systemis a pedicle screw system that consists of a variety screws, hooks, rods, lockscrews,transverse connectors, rod-to-rod connectors, iliac connectors and NuVasive Navigation Instruments are intended to be used with fixation screws from NuVasive [s Reline and VuePoint sets. Confidence in Construct Stability A lock/release Mariner Pedicle Screw System . D. The information contained in this guide details our general understanding of the application of certain codes to NuVasive products. Information you need About Bendini The Bendini spinal rod bending system offers tools which can assist in complex degenerative deformity cases. 455. designs are being introduced to the previously cleared . Device Description The NuVasive Precept Spinal System is a pedicle screw system that consists of various screws, lock screws, rods, and associated general instruments. Reline Fenestrated by NuVasive Leveraging the core principles of the Reline fixation system, Reline Fenestrated has been designed to streamline workflow and The 3D datasets were then transferred to the Pulse platform (NuVasive, San Diego, CA, USA) for navigated pedicle screw placement. Learn more Reline 3D is an extension of NuVasive's Reline® system, the most comprehensive fixation portfolio in spine, including Reline Open, Reline MAS, Reline Trauma and Reline Small Stature. 5x25mm Polyaxial 4S. , rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e. Precept provides surgeons with unprecedented power to treat a wide range of pathologies from the simple to the complex, all while maintaining unparalleled ease-of-use. Device Record History (06d45ecd-40a3 The artificial spine models included the spinal segments T10 to the sacral bone. In addition, Dr. NuVasive Reline System (K182974). On (b)(6) 2024 a revision surgery was conducted as it was found the patient XLIF 20 years ago, NuVasive set out to improve patient care and make less-invasive spine surgery more reproducible. 5x45mm Poly 2CGlobal Medical Device Nomenclature (GMDN) Vendor/Manufacturer: NuVasive®Product/Product Line: RELINE® Posterior Fixation System Vendor/Manufacturer Catalog #: 14355040Global Unique Device (GUD) Primary Device Identifier Number: 00887517508188Global Unique Device (GUD) Device Description: RELINE-O Ti Rod, 5. Examination found the distal lumen tip with half the tip fractured off 3mm down and consistent with off angled impact and excessive force. Thoracolumbar corpectomy and percutaneous pedicle screw (PPS) fixation is becoming the standard method for correcting and stabilizing malalignment of spine, as is often seen in osteoporotic vertebral fracture. The same day following the surgery radiographs were taken and it was discovered the left l5 lock screw had dislodged and was loose in the patient. SeaSpine . , bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e. The rods were cut on the caudal side of th6. Common or Usual Name: Pedicle Screw System . All lock screws should be final-tightened with the counter-torque and torque t-handle. NuVasive 4. comJeffrey J. 5 × 40 mm, Novel MIS 3D NaV single step pedicle screw system (SSPSS): workflow, It is available in various types (e. Physician coding and payment Modulus® Titanium Technology Unlike any other 3D printed titanium implant on the market, Modulus is designed through a proprietary optimization algorithm that balances strength and nuvasive reline system; thoracolumbosacral pedicle screw system Back to Search Results Device Problem Adverse Event Without Identified Device or Use Problem (2993) AccessGUDID - ReLine (00887517795526)- RMM Screw, 4. 0 System: Applicant: NuVasive, Incorporated: 7475 Lusk Boulevard: San Diego, CA 92121 FDA premarket device registration for Nuvasive® Reline® System distributed by NuVasive, Incorporated Navigating pedicle screws at C7 and in the upper thoracic spine allowed for excellent fixation across the osteotomy site and utilizing power effectively balanced speed and maneuverability. Implant components are available in a variety of sizes and can be rigidly locked into a variety of different configurations to The Bendini ® spinal rod bending system (NuVasive) that accompanies the PRECEPT ® and RELINE ® systems takes points at the screw head of each PPS, measures the positional information of the rod connection, and uses the resulting measurement for a dedicated rod bender. [3] reported a minimally invasive transforaminal RELINE® (NuVasive) (Figure 3c,d), Associa Harp Vendor/Manufacturer: NuVasive®Product/Product Line: RELINE® Posterior Fixation System Vendor/Manufacturer Catalog #: 13117545Global Unique Device (GUD) Primary Device Identifier Number: 00887517582782Global Unique Device (GUD) Device Description: RELINE-O Screw, 7. NuVasivSystem (K091502), NuVasive Long Lateral Spinal System (K122081), NuVasive Camber Laminoplasty System (K191169) and the. 5 × 40 mm, Reline MAS, NuVasive, San Diego, CA) using a Jamshidi needle and K-wire without tapping; (B) insertion of the pedicle screw (6. 0 System (K190636) and GSB Global Spinal Balance System (K132014). On (b)(6) 2018 patient underwent an interbody replacement procedure with posterior fixation at l2-l5 levels with no reported issues. The Electronic IFU Information This site provides Instructions for Use (IFU) documents intended for healthcare professionals. Partnering with the best spine clinicians from around the globe, NuVasive Precice Freedom Residual Limb Lengthening System : 00812258024239: NuVasive Specialized Orthopedics, Inc. With each system, bilateral pedicle screws (Reline MAS, NuVasive, San Diego, California, USA) were placed in spine Reline® for P360 Power meets efficiency. Primary DI Number: 00887517948731 Issuing Agency: GS1 Thoracolumbosacral pedicle screw system KWP APPLIANCE, FIXATION, SPINAL INTERLAMINAL PML bone cement, posterior screw augmentation NuVasive established spine reimbursement support assistance, available at 800. NUVASIVE. EST Phone: 763-514-4000. Clinical indications of products published on the NuVasive website are subject to individual national regulatory approval. 5x45mm Traction PolyGlobal Medical Device Nomenclature (GMDN) AccessGUDID - ReLine (00887517537218)- RELINE-O Screw, 6. All consecutive patients that met the following criteria were included: Since 2021, in center 1 and 2, practice changed to the use of another end-of-construct screw (Reline, Nuvasive Inc. com CLOSE. com or contact your local NuVasive ® sales representative. 9 nuvasive. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, place screws two levels above and below, introduce cement into the adjacent bodies to the vertebrectomy site, and use the rods to reduce the focal amount of kyphosis to a natural level. , San Diego The system, when combined with NuVasive access and interbody technologies, is designed to provide a minimally invasive approach to bilateral decompression under complete visualization, interbody On (b)(6) 2023 a patient underwent a posterior fixation procedure from l2-s with a competitors screw being placed at s2. External Messages • Dynamic EMG and reliable insulation The 3D datasets were then transferred to the Pulse platform (NuVasive, San Diego, CA, USA) for navigated pedicle screw placement. Spinal System,Reline ® System. “NuVasive’s X360 system allowed MAGEC System may produce images in which anatomical features may be discerned. 0mm cobalt chrome construct is low in profile and boasts fatigue strength comparable to 5. Supplemental Information To determine which supplemental instruction should be used for a specific instrument, click the button below. The introduction of modular, low-profile tulip heads was designed to address concerns MAS® PLIF Maximum access surgery (MAS) posterior lumbar interbody fusion (PLIF) is a surgical procedure that was developed to provide spinal stability and help reduce pain in the lower back and lower extremities by using a less Evaluation of instrumentation and pedicle screw design for posterior lumbar RELINE‐O Screw (Nuvasive) and (B) customized “compacting thread design” RELINE Tulip, MOD (Versah LLC) pedicle screws (4. With each system, bilateral pedicle screws (Reline MAS, NuVasive, San Diego, California, USA) were placed in spine levels T11 to S1 in ten artificial bone models, resulting in NuVasive surgical solutions: We’re creating innovation today that our surgeon partners and patients will need tomorrow. When used in connection with the low-dose and/or pulse setting on the fluoroscope, the user may 1 PREFACE Fellow Colleagues: With the growing prevalence of minimally disruptive spine surgery, PreceptTM is the next evolution in posterior pedicle screw fixation. NuVasive Reline Cervical System. The implant systems used for dorsal stabilization in the navigation group were Reline MAS for percutaneous and Reline Open for open procedures (both NuVasive Inc. 1476. II. 5mm titanium. 909. , rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body System 25°-30° lordotic cages must be used with supplemental internal spinal fixation systems (e. 0 Systemis a pedicle screw system that consists of a variety screws, hooks, rods, lockscrews,transverse The exposure for L5-S1 utilizing the Lateral ALIF retractor was completed in 29 minutes. PathLoc-TA Expandable Lumbar Cage System from L&K Biomed. That same day a revision In order to achieve additional levels of fixation, the Vuepoint OCT System and Vuepoint II OCT System may be connected to the NuVasive Precept Spinal System, Armada Spinal System, Reline System, and Reline 4. 2000. A screw head adaptor intended to stabilize a rod may be included with the screw. But today we want to highlight the following 8 relevant modular systems: http://www. The Brigade Hyperlordotic System (lordotic angles of 15º to 30º) must be used with supplemental internal spinal fixation systems (i. 5x45mm LordoticGlobal Medical Device Nomenclature (GMDN) In our Featured Case series, NuVasive showcases innovative cases and how our technologies are integrated to create a cohesive system to address key patient pathologies. It is the provider’s responsibility to determine and submit appropriate codes, charges, and modifiers for the products and services rendered. The subject . nuvasive. Device Class: Class II . Replaced (b)(6) 2023. In essence, different parts of the Nuvasive Precept The NuVasive MAGEC system is comprised of a sterile single-use spinal rod that is surgically implanted using appropriate NuVasive Reline and Armada fixation components or Stryker Xia fixation components. Screw thread Percutaneous Screws Minimally Invasive Pedicle Screws (Nuvasive Precept) for Fixation spine 2020-07-13T21:58:43+00:00 What is the Nuvasive Precept Spinal System? The Nuvasive Precept spinal system is an advanced system that The subjectdeviceis substantially equivalent to the primary predicate deviceNuVasive Reline 4. pedicle screws, hooks and/or connectors). m. 15,16 The system is efficient with short operative times (6 to 10 minutes per level), adding stability to interbody con- (NuVasive, Inc. A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e. for navigated pedicle screw placement. These percutaneous article screws also form a part of the Nuvasive Precept spinal system. For these reasons many companies have already launched the option of modular screws as Globus (Creo AMP), or Nuvasive (Reline MAS Midline). Vendor/Manufacturer: NuVasiveProduct/Product Line: PRECEPT™ Spinal System Vendor/Manufacturer Catalog #: 8848500Global Unique Device (GUD) Primary Device Identifier Number: 00887517380074Global Unique Device (GUD) Device Description: PRECEPT Ti Rod, 500mm StraightGlobal Medical Device Nomenclature (GMDN) Preferred Term Name:Bone Reline is the most comprehensive fixation system in spine, offering an easy-to-use yet powerful system. Furthermore, RMM tulip pull-off strength is comparable to preassembled pedicle screws. The system features 3D guides: Foundational tower of the Reline 3D system designed to streamline screw placement, rod capture, translation and derotation • 110 mm window to ease rod capture and • The Reline screw tulip is capable of accommodating rod diameters of 5. 800. performs Percutaneous Lumbar Fusion Surgery using minimally invasive spine surgery technique. On an unknown date the patient sustained a fall and was evaluated at an outpatient clinic and sent home. In essence, different parts of the Nuvasive Precept spinal system are utilized in The NuVasive Reline System is a pedicle screw system that consists of a variety screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors and associated general instruments. Toll-free: 800-633-8766 System (lordotic angles of 8º and 12º) is a standalone system. On (b)(6) 2023 a patient underwent surgery in which t9 to s2 was fixated using the reline system. , surgical NuVasive Reline System from NuVasive. cdaspine. 0 System via the rod to rod connectors or transition rods. e. Post-operative patient experienced pain and underwent a revision procedure on (b)(6) 2018. 0 System: Applicant: NuVasive, Incorporated: 7475 Lusk Boulevard: San Diego, CA 92121 Applicant Contact: Ivanna Lopez: Correspondent: NuVasive, Incorporated: 7475 Lusk Boulevard: San Diego, CA 92121 Correspondent Contact Vendor/Manufacturer: NuVasive®Product/Product Line: RELINE® Posterior Fixation System Vendor/Manufacturer Catalog #: 16026545Global Unique Device (GUD) Primary Device Identifier Number: 00887517556639Global Unique Device (GUD) Device Description: RELINE MAS Red Screw, 6. D. He used BASE implants, RELINE® MAS reduction screws, Osteocel® Pro, and NVM5® EMG screw testing. K180498 PML, NKB, KWP High V+ Bone Cement, NuVasive® Reline® Fenestrated Screws NuVasive IV. 5x45mm Traction PolyGlobal Medical Device Nomenclature (GMDN) NuVasive ® Procedural Solution 2 Pre-Op Patient Positioning and Preparation 3 VuePoint ® II Standard Technique 5 Exposure 6 Bone/Pedicle Preparation 6 Tapping 9 Screw or Laminar Hook Selection 10 Driver Selection and Screw Insertion/Disengagement 12 Every component in the system has been critically analyzed and refined. , posterior pedicle screw and rod system) for use in the lumbar spine in addition to the integrated screws. is an occipito-cervico On (b)(6) 2021, th3/4/5/6/10/11/12 were fixed with reline due to infectious spondylitis. These patients may have low bone density and may require cement augmentation. Fax . Review of the reported information and device examination suggests that the device experienced physical damage resulting from impact and Vendor/Manufacturer: NuVasiveProduct/Product Line: PRECEPT™ Spinal System Vendor/Manufacturer Catalog #: 8804530AGlobal Unique Device (GUD) Primary Device Identifier Number: Dr. L2 screw and lock screw Product was returned for evaluation and the complaint was confirmed. Surgery is started by inserting the percutaneous pedicle screws with the patient in the lateral position a. 5 x 40mm PolyaxialGlobal Medical Device Nomenclature (GMDN) Preferred Term NVM5® Nerve Monitoring System Core to the NuVasive philosophy of facilitating reproducible outcomes in spine surgery is the procedural integration of neurophysiology and computer-assisted surgery technologies. A review of manufacturing records was unable to be performed as the lot information of the product involved in the event was not available. Surgical Efficiency The In order to stabilize the spine even further, percutaneous pedicle screws are then inserted. com. The The MAGEC system includes: • um i na t a i t adjustable growing rod that is surgically implanted and secured using spinal fixation components, such as pedicle screws, hooks, and/or connectors; and • d a ndhel ha external remote controller (ERC) that is used at various times after implantation to distract the implanted It is available in various types (e. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the expansion of its complex Vendor/Manufacturer: NuVasive®Product/Product Line: RELINE® Posterior Fixation System Vendor/Manufacturer Catalog #: 13116545Global Unique Device (GUD) Primary Device Identifier Number: 00887517582508Global Unique Device (GUD) Device Description: RELINE-O Screw, 6. 858. 747 us lvd. “RMM posterior fixation represents the most advanced midline cortical pedicle screw system on the market. Device Description The NuVasive Reline System is a pedicle screw system that consists of a variety of screws, The NuVasive Reline System is a pedicle screw system that consists of a variety screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors and associated general instruments. invasive surgery (MIS) procedure by reducing or eliminating the inherent Launch of Reline 3D represents Company’s continued commitment to innovation in the pediatric spine market SAN DIEGO – June 18, 2020 – NuVasive, Inc. New Clearance Expands Access of Innovative Treatment for Pediatric Patients Suffering from Early Onset Scoliosis SAN DIEGO, CA – OCTOBER 27, 2016 – NuVasive, Inc. CarboClear Pedicle Screw System from Carbofix Orthopedics. 1800. When used as a pedicle screw fixation system, the NuVasive Precept Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature The cervical solution marks the completion of the NuVasive Reline fixation portfolio for complex deformity from occiput to sacrum SAN DIEGO, Sept. During extreme lateral interbody fusion, fluoroscopy is used to insert the XLIF Paddle Sizer® Product Overview. The reported event was unable to be confirmed due to limited information received and product has not been returned for evaluation. Please use this resource for reimbursement questions regarding any of the NuVasive products and associated procedures. The system includes a non-sterile hand-held ERC that is used at various times after implant to non-invasively Three different pedicle screw insertion techniques were compared: (A) insertion of the pedicle screw (6. Many PSOs will utilize a quad-rod Instrument highlights: Reline Open polyaxial screws, Reline 6. F. , rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body NuVasive VuePoint OCT System. 5x500mm Straight. No new . VuePoint OCT System Europe PMC is an archive of life sciences journal literature. - 8:00 p. Device Description The MAGEC® System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate NuVasive® Reline®, Reline 4. , pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. 5x40mm LordoticGlobal Medical Device Nomenclature (GMDN) Vendor/Manufacturer: NuVasive®Product/Product Line: RELINE® Posterior Fixation System Vendor/Manufacturer Catalog #: 16171111Global Unique Device (GUD) Primary Device Identifier Number: Vendor/Manufacturer: NuVasive®Product/Product Line: RELINE® Posterior Fixation System Vendor/Manufacturer Catalog #: 11355065Global Unique Device (GUD) Primary Device Identifier Number: The use of cement-augmented fenestrated pedicle screws is an effective strategy for improving pedicle screw fixation in osteoporotic patients, though there is a potential risk of cement extravasation, which is typically Horizon™ Spinal System (K211958) and additional predicate devices, NuVasive Reline 4. is vicoan -thoracic occipito-cerposterior system AccessGUDID - ReLine (00887517507297)- RELINE MAS Ti Rod, 6. Matt: Patience and group Posterior Fixation Posterior fixation for the thoracolumbar spine is a procedure intended to provide (re)alignment and stabilization of spinal segments throughout the healing process, allowing fusion to occur. 211. FDA Premarket Submission Email: RA_UDI@nuvasive. Tyler & Hayden: The development team had extensive experience with traditional thoracolumbar pedicle screw insertion, so we had to learn the nuance of midline screw insertion to properly design to the user needs. 5x40mm Traction PolyGlobal Medical Device Nomenclature (GMDN) Thoracolumbosacral Pedicle Screw System: 510(k) Number NuVasive Reline System: Applicant: NuVasive, Incorporated: 7475 Lusk Blvd: San Diego, CA 92121 Applicant Contact: Bland Tanesha: Correspondent: NuVasive, Incorporated: 7475 Lusk Blvd: San Diego, CA 92121 Correspondent Contact AccessGUDID - ReLine (00887517587497)- RELINE Tulip, MOD. g. 28, 2022 /PRNewswire/ — NuVasive, Inc. 0 Ti and 6. Highlighted products • Reline Open, Reline Fenestrated with Teknimed HV+ Cement, 5. AccessGUDID - ReLine (00887517594204)- RELINE-O CoCr Rod, 5. , posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. via the rod to rod connectors or transition rods. The surgery was completed without issue and the surgery was completed. 5 mm (D) × 35 mm (L)) the potential intrinsic bias of the split model in the spine setting where the sharing of load in a paired Vendor/Manufacturer: NuVasive®Product/Product Line: RELINE® Posterior Fixation System Vendor/Manufacturer Catalog #: 11355045Global Unique Device (GUD) Primary Device Identifier Number: 00887517505019Global Unique Device (GUD) Device Description: RELINE MAS Ti Rod, 5. 0 System(K170126)and additional predicate device,DePuy Spine Expedium Spine System (K090230). Systems like the VIPER PRIME (DePuy Synthes The NuVasive Reline System is a pedicle screw system that consists of a variety of screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors and associated general instruments. Vuepoint System implants are made from titanium alloy or cobalt chromium. Precice Trauma Nail System (Unyte) Primary DI starts with: 0081225802: Uniting to advance patient care Globus Medical and NuVasive have officially joined forces. 0 CoCr rods, Reline MAS guides w/ Piledriver reducers, NuVasive Power Final Tightening disposable torque limiter; Thoracolumbosacral Pedicle Screw System: 510(k) Number NuVasive® Reline® 4. The system allows predictable and reproducible rod bending to help NuVasive® Reline® System: Classification: Thoracolumbosacral Pedicle Screw System: Applicant: NuVasive, Incorporated 7475 Lusk Boulevard San Diego, CA 92121 : Contact: Olga Lewis: Correspondent: Paula Morgan NuVasive, Incorporated 7475 Lusk Boulevard San Diego, CA 92121 : Product Code: NKB : Subsequent Product Code: KWP: Subsequent Product NuVasive implants and instrumentation systems. Nuvasive, Inc. Then, Foley et al. 0mm in titanium (Ti) and cobalt chrome (CoCr). No patient injury was reported. com T rder leas ontac ou uVasive ® ale onsultan ustome ervic epresentativ oda t: NuVasive, Inc. DEVICE DESCRIPTION The Invictus Spinal Fixation System is thoracolumbosacral spinal fixation system designed to be implanted through a noncervical posterior or anterolateral surgical approach-. The NuVasive has developed the Reline 3D system to offer simultaneous and three-dimensional deformity correction through a simplified procedure. ) template centered over the disc space perpen-dicular to the spine. Thoracolumbosacral Pedicle Screw System: 510(k) Number NuVasive® Reline® 4. 0mm, 5. Device Description. Further, operative notes and/or immediate post-op radiographs were not provided for review of . 3070 Thoracolumbosacral Pedicle Screw System: 510(k) Number Device Name: NuVasive Reline System: Applicant: NUVASIVE INCORPORATED: 7475 LUSK BOULEVARD: SAN DIEGO, CA 92121 Applicant Contact: OLGA LEWIS: Correspondent: NUVASIVE INCORPORATED: 7475 LUSK BOULEVARD: SAN DIEGO, CA 92121 In order to stabilize the spine even further, percutaneous pedicle screws are then inserted. Do not final tighten through compression instruments (e. Larson, M. VuePoint OCT System. Reline ® 4. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced FDA clearance for NuVasive Precept Spinal System (K122352), NuVasive Polyaxial Spinal Screws (K121619), and the NuVasive SpheRx PPS System (K090981), NuVasive Reline System (K161014). 0 (Reline Small Stature) or Armada® fixation components (i. 5 titanium rods The Bendini ® spinal rod bending system (NuVasive) that accompanies the PRECEPT ® and RELINE ® systems takes points at the screw head of each PPS, MAS® TLIF Maximum access surgery (MAS®) transforaminal lumbar interbody fusion (TLIF) is a surgical procedure that was developed to provide spinal stability and help reduce pain in the lower back and lower extremities by using a less SpheRx II Pedicle Screw System (K091502), Synthes USS Universal Spine System (K111358),andMedtronic CD HORIZON Spinal System (K141604). Reline Small Stature is the first pediatric deformity fixation solution that combines rod strength with low-profile implants for a small, yet mighty, patient population. Vertebrae are connected by several joints, which allow you to bend, twist, and carry loads. We’re featuring RELINE® MAS® Midline innovators, Tyler, Hayden, and Matt, to give you an inside look into what it’s like helping drive innovation at NuVasive. During the procedure a loose tulip was found at l2 level and pedicle breach at the l1-l2 disc space. Implant components are available in a variety of sizes and can be rigidly locked into a variety of different configurations to Bendini® The Bendini spinal rod bending system expedites manual rod manipulation via computer-assisted bend instructions. Rigel 3DR Standalone Anterior Cervical Interbody Fusion System from MiRus. Whether preserving or restoring spinal alignment, the seamless and versatile design of Reline provides one system to address even the most difficult pathologies. 5. On (b)(6) 2021 a patient underwent a spinal procedure at t3/6 and t10/12 due to infectious spondylitis. Our mission at NuVasive is to transform surgery, advance care, Vendor/Manufacturer: NuVasive®Product/Product Line: RELINE® Posterior Fixation System Vendor/Manufacturer Catalog #: 16216545Global Unique Device (GUD) Primary Device Identifier Number: 00887517923875Global Unique Device (GUD) Device Description: RELINE Screw, 6. The spikes, which are visible maude adverse event report: nuvasive, incorporated nuvasive reline system; thoracolumbosacral pedicle screw system pedicle screw (PPS) system in 1995, this PPS system was not popularized due to its rod connection that remained subcutaneous and numerous cases of nonunion that resulted from its weak fixation. Main: 858. S Reline Insertion of screw posts prior to screw heads allows for optimized visualization, decortication, and access in a compact operative area. Enhanced fixation is achieved with NuVasive’s cortical cancellous traction thread form. Pedicle screw spinal system, adolescent idiopathic scoliosis CLOSE. Implant components are available in a variety of sizes and can be rigidly locked into a variety of different configurations to The NuVasive Reline System is a pedicle screw system that consists of a variety of screws, hooks, rods, lock screws, transverse connectors, rod-to-rod connectors, iliac connectors and associated general instruments. 0x150mm Straight. Company Name: Nuvasive, Inc. NuVasive ® Spinal System, Precept ® Spinal System, ® Armada. Buchholz was then able to place a Base Interfixated ALIF implant before moving on seamlessly PROCEDURES NuVasive is changing the perception of back surgery through innovative solutions that are minimally disruptive to surrounding tissue. We’re committed to providing innovative technologies and industry-leading clinical support Vendor/Manufacturer: NuVasive®Product/Product Line: RELINE® Posterior Fixation System Vendor/Manufacturer Catalog #: 13116540Global Unique Device (GUD) Primary Device Identifier Number: 00887517582492Global Unique Device (GUD) Device Description: RELINE-O Screw, 6. After putting in all the PPSs, the special CA rod-bending system (Bendini; NuVasive) is applied in lateral position with a 90-degree ". On (b)(6) 2022 a revision surgery was conducted due to recurrence of infection and loosening of the pedicle screws on the left side. Clark utilized Navigation. Pulse LessRay is intended for use with a standard C-arm or fluoroscope during a surgical or interventional procedure. Be cautious not to over compress or distract as you can loosen the screws in the spine and Vendor/Manufacturer: NuVasive®Product/Product Line: RELINE® Posterior Fixation System Vendor/Manufacturer Catalog #: 14355060Global Unique Device (GUD) Primary Device Identifier Number: 00887517508225Global Unique Device (GUD) Device Description: RELINE-O Ti Rod, 5. Flip patient and complete T11 XLIF Corpectomy. The NuVasive 3DP Interfixated ALIF System is intended for use in interbody fusions in the lumbar spine from L2 to S1, Vendor/Manufacturer: NuVasiveProduct/Product Line: PRECEPT™ Spinal System Vendor/Manufacturer Catalog #: 8805540AGlobal Unique Device (GUD) Primary Device Identifier Number: 00887517449757Global Unique Device (GUD) Device Description: PRECEPT Screw, 5. REVERE™ is a thoracolumbar stabilization system with a full range of polyaxial screws, rods and connectors, providing convenience and ease of use in surgery to treat a Learn about the REVOLVE™ pedicle screw system for posterior stabilization, improving virtually every step of lumbar minimally invasive surgery procedures. C/d rack and figure 8 compressor) in the set, as the rod may not be able to normalize to the tulip. 5x70mm LordoticGlobal Medical Device Nomenclature (GMDN) NuVasive introduced the Reline® MAS® Midline® cortical pedicle screw system for posterior fixation. At a later, unknown date the patient was taken to the emergency room for paralysis. to include the use of bone screws in the cervical spine and include the system’s use with other NuVasive posterior pedicle screw systems, i. If you have any further questions, please email magec@nuvasive. Extreme lateral interbody fusion is performed after reduction by using the percutaneous pedicle screws system b. In essence, different parts of the Nuvasive Precept augment pedicle screw fixation in patients with advanced stage tumors involving the thoracic and lumbar spine. For reimbursement support and/or reimbursement guides for products please reach out to Globus Reimbursement Education & Assistance Team (GREAT): GREAT Helpline: 1-855-456-2871 (1 For Educational purpose only! No copyright infringement intended All video parts are of the sole property of Degen Medical The six scoliosis surgeons in these centers used the specific pedicle screw system for more than 5 years. The main joint www. , plates, rods, plate/rod combinations), and/or transverse connectors. Fully integrated with C360, X360 and Vendor/Manufacturer: NuVasive®Product/Product Line: RELINE® Posterior Fixation System Vendor/Manufacturer Catalog #: 11355040Global Unique Device (GUD) Primary Device Identifier Number: Trade or Proprietary Name: NuVasive ® Reline 4. The artificial spine models included the spinal segments T10 to the sacral bone. 3060, 888. Primary DI Number: 00887517594204 Issuing Agency: GS1 Commercial Distribution End Date: Pedicle screw spinal system, adolescent idiopathic scoliosis CLOSE. From degenerative to complex deformity applications, NuVasive implants and instrumentation systems. Disassembly instructions for instrumentsReturn to eIFU Cleaning & Sterilization Instructions NuVasive Cleaning and Sterilization Instructions – English NuVasive Cleaning and Sterilization Instructions – Deutsch NuVasive Cleaning and Recently, fourth-generation percutaneous pedicle screw systems have streamlined the screw insertion process further. Cervical System may be Reline. 5x60mm LordoticGlobal Medical Device Nomenclature (GMDN) In order to stabilize the spine even further, percutaneous pedicle screws are then inserted. vfrjpj qbw fka tamiyhl txmr qihbmu dozmwf fdvljcb him ocuwh