NuVasive Inc
San Diego, CA, US
NUVASIVE, INC. appears in FDA device records in San Diego, CA. FDA records list 92 510(k) clearances between and , 26 PMA records and 2 registered establishments. As of , FDA records show 36 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 92FDA records hold 92 510(k) clearances for NuVasive Inc between 1999 and 2024. The busiest year on record is 2007, with 9. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 2 |
| 2000 | 3 |
| 2001 | 2 |
| 2002 | 2 |
| 2003 | 4 |
| 2004 | 4 |
| 2005 | 4 |
| 2006 | 6 |
| 2007 | 9 |
| 2008 | 6 |
| 2009 | 9 |
| 2010 | 6 |
| 2011 | 6 |
| 2012 | 9 |
| 2013 | 9 |
| 2014 | 4 |
| 2015 | 2 |
| 2017 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233706 | Bendini Cloud Application | OLO | Substantially Equivalent | |
| K240507 | NuVasive AttraX Scaffold | MQV | Substantially Equivalent | |
| K223731 | NuVasive Modulus-C Interbody System | ODP | Substantially Equivalent | |
| K211757 | Simplify Disc | QLQ | Substantially Equivalent | |
| K173117 | NuVasive® VersaTie™ System | OWI | Substantially Equivalent | |
| K141665 | NuVasive CoRoent System | MAX | Substantially Equivalent | |
| K142205 | NuVasive X-CORE(R) Expandable VBR System | MQP | Substantially Equivalent | |
| K141968 | NUVASIVE NVM5 SYSTEM | PDQ | Substantially Equivalent | |
| K140319 | COROENT TI-C SYSTEM | MAX | Substantially Equivalent | |
| K140162 | AP EXPANDABLE XLIF SYSTEM | MAX | Substantially Equivalent | |
| K140003 | COROENT SMALL INTERBODY SYSTEM | ODP | Substantially Equivalent | |
| K133052 | AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM | PEK | Substantially Equivalent | |
| K131025 | ARCHON ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K132014 | GSB GLOBAL SPINAL BALANCE SYSTEM | NKB | Substantially Equivalent | |
| K131723 | COROENT SINGLE TAB SYSTEM | OVD | Substantially Equivalent | |
| K130868 | NUVASIVE DECADE LATERAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K131238 | AFFIX SPINOUS PROCESS PLATE SYSTEM | PEK | Substantially Equivalent | |
| K123307 | NUVASIVE NVM5 SYSTEM | PDQ | Substantially Equivalent | |
| K123045 | BRIGADE STANDALONE SYSTEM | OVD | Substantially Equivalent | |
| K122081 | NUVASIVE LONG LATERAL SPINAL SYSTEM | KWQ | Substantially Equivalent | |
| K122742 | NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM | OLO | Substantially Equivalent | |
| K121815 | NUVASIVE SAGE LATERAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K122352 | NUVASIVE PRECEPT SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K121619 | NUVASIVE POLYAXIAL SPINAL SCREWS | NKB | Substantially Equivalent | |
| K121837 | NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K120918 | NUVASIVE COROENT TITANIUM SYSTEM | MAX | Substantially Equivalent | |
| K112717 | NUVASIVE NVJJB SYSTEM | ETN | Substantially Equivalent | |
| K112718 | NUVASIVE NVM5 SYSTEM | ETN | Substantially Equivalent | |
| K112561 | NUVASIVE COROENT NO-PROFILE SYSTEM | OVD | Substantially Equivalent | |
| K111811 | BENDINI(TM) SPINAL ROD BENDING SYSTEM | OLO | Substantially Equivalent | |
| K111597 | DISPOSABLE STIMULATING ELECTRODE | ETN | Substantially Equivalent | |
| K111866 | NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K111410 | NUVASIVE LONG LATERAL SPINAL SYSTEM | KWQ | Substantially Equivalent | |
| K103750 | NUVASIVE TRAVERSE PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K102547 | COROENT INTERLOCK SYSTEM | OVE | Substantially Equivalent | |
| K102514 | NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K101284 | FACET SCREW SYSTEM | MRW | Substantially Equivalent | |
| K093319 | NUVASIVE VUEPOINT OCT SYSTEM | KWP | Substantially Equivalent | |
| K100043 | COROENT XLR STANDALONE SYSTEM | OVD | Substantially Equivalent | |
| K094054 | MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE | GWF | Substantially Equivalent | |
| K093804 | NUVASIVE HELIX REVOLUTION ACP SYSTEM | KWQ | Substantially Equivalent | |
| K091623 | LAMINOPLASTY FIXATION SYSTEM | NQW | Substantially Equivalent | |
| K092287 | NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | |
| K091502 | NUVASIVE SPHERX II SYSTEM | NKB | Substantially Equivalent | |
| K090981 | MODIFICATION TO: NUVASIVE SPHERX SYSTEM | NKB | Substantially Equivalent | |
| K090298 | NUVASIVE NEURO VISION SYSTEM | GWF | Substantially Equivalent | |
| K091071 | NUVASIVE LATERAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K090176 | NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM | MQP | Substantially Equivalent | |
| K083341 | NUVASIVE HELIX-T ACP SYSTEM | KWQ | Substantially Equivalent | |
| K081377 | NUVASIVE SURGICAL MESH SYSTEM | FTL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2031966 | 3002980729 | NUVASIVE, INC. | 7475 Lusk Blvd, SAN DIEGO, CA 92121 US | 2026 | and 50 more, listed in full below |
| 3009144915 | 3009144915 | NUVASIVE, INC. | City View Plaza 1 Suites 116 & 117, Guaynabo, PR 00968 US | 2026 | and 32 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NBHAccessories, Arthroscopic
- HSTApparatus, Traction, Non-Powered
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HRXArthroscope
- HWJAwl
- HTWBit, Drill
- IKDCable, Electrode
- BSKCuff, Tracheal Tube, Inflatable
- HWRDriver, Prosthesis
- IKNElectromyograph, Diagnostic
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- HTEElevator
- HWBExtractor
- MQVFiller, Bone Void, Calcium Compound
- MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)
- HTDForceps
- HTJGauge, Depth
- HWAImpactor
- HWNInstrument, Compression
- OWBInterventional Fluoroscopic X-Ray System
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- FSTLight, Surgical, Fiberoptic
- HXLMallet
- EZXMesh, Surgical, Metal
- FTLMesh, Surgical, Polymeric
- HAWNeurological Stereotaxic Instrument
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- NQWOrthosis, Spine, Plate, Laminoplasty, Metal
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- HRSPlate, Fixation, Bone
- NKGPosterior Cervical Screw System
- JDKProsthesis, Hip, Cement Restrictor
- MJOProsthesis, Intervertebral Disc
- GADRetractor
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- MQPSpinal Vertebral Body Replacement Device
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- GWFStimulator, Electrical, Evoked Response
- ETNStimulator, Nerve
- BXMStimulator, Nerve, Ac-Powered
- INKStretcher, Wheeled, Powered
- MRWSystem, Facet Screw Spinal Device
- LLZSystem, Image Processing, Radiological
- JACSystem, X-Ray, Film Marking, Radiographic
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- FTYTape, Measuring, Rulers And Calipers
- HWTTemplate
- NKBThoracolumbosacral Pedicle Screw System
- BTRTube, Tracheal (W/Wo Connector)
- HXCWrench
Recall records
Showing 25 of 36| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0738-2023 | X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation. | Potential that insert will be unable to disengage from the vertebral body replacement device/implant | Class II | Open, Classified | |
| Z-1052-2023 | NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US | Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremity procedures. | Class III | Open, Classified | |
| Z-1453-2022 | Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4; Simplify Disc Size 2, Ht 5/MD-5; Simplify Disc Size 2, Ht 5, 5/MD-5L; Simplify Disc Size 2, Ht 6/MD-6; Simplify Disc Size 2, Ht 6, 5/MD-6L; Simplify Disc Size 3, Ht 5/LG-5; Simplify Disc Size 3, Ht 5, 5/LG-5L; Simplify Disc Size 3, Ht 6/LG-6; Simplify Disc Size 3, Ht 6, 5/LG-6L | Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may also contain the incorrect GTIN human readable text, which could lead to selecting an incorrectly sized unit. | Class II | Open, Classified | |
| Z-2684-2020 | Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery. | The NVM5 EMG Module kit intended for intraoperative neurophysiologic monitoring during spinal surgery contains incorrect component, part number 1715945, SSEP harness instead of the the correct part number 1747065, NVM5 Harness, Gen 3.5 EM. This issue can result in delay in therapy or lack of EMG neuromonitoring during surgery if the surgeon elects to proceed without the NVM5. | Class II | Terminated | |
| Z-1898-2020 | NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usage: comprised of a sterile single-use spinal rod that is surgically implanted using appropriate NuVasive Reline, Reline Small Stature, and Armada fixation components (i.e. Pedicle screws, hooks and/or connectors, provided non-sterile, to be sterilized by the end user). | Post-implantation separation of an actuator end cap component that may expose internal components of the actuator, which could lead to hastened degeneration of the internal components and egress of Titanium alloy wear debris and resultant localized tissue discoloration. | Class II | Terminated | |
| Z-0378-2013 | 7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | Terminated | |
| Z-0377-2013 | 7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | Terminated | |
| Z-0376-2013 | 7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | Terminated | |
| Z-0375-2013 | 6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | Terminated | |
| Z-0374-2013 | 6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | Terminated | |
| Z-0373-2013 | 6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | Terminated | |
| Z-0372-2013 | 5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | Terminated | |
| Z-0371-2013 | 5.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | Terminated | |
| Z-0370-2013 | 5.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | Terminated | |
| Z-0369-2013 | 4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | Terminated | |
| Z-0368-2013 | 4.5mm x 35mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | Terminated | |
| Z-0367-2013 | Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | Terminated | |
| Z-0366-2013 | 7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | Terminated | |
| Z-0365-2013 | 7.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | Terminated | |
| Z-0364-2013 | 7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | Terminated | |
| Z-0363-2013 | 7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | Terminated | |
| Z-0362-2013 | 7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | Terminated | |
| Z-0361-2013 | 7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | Terminated | |
| Z-0360-2013 | 6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | Terminated | |
| Z-0359-2013 | 6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI | The tulip portion of the screw assembly can disengage from the shank after implantation. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain