Nuvasive, Inc.
Medical device manufacturer in San Diego, CA.
92510(k) clearances
1PMA approvals
36recalls
Device types
- KWQ Appliance, Fixation, Spinal Intervertebral… 21
- NKB Thoracolumbosacral Pedicle Screw System 9
- MQP Spinal Vertebral Body Replacement Device 6
- ETN Stimulator, Nerve 6
- MAX Intervertebral Fusion Device With Bone… 5
- GWF Stimulator, Electrical, Evoked Response 5
- MRW System, Facet Screw Spinal Device 4
- OVD Intervertebral Fusion Device With… 4
- MNH Orthosis, Spondylolisthesis Spinal Fixation 4
- OLO Orthopedic Stereotaxic Instrument 3
- ODP Intervertebral Fusion Device With Bone… 3
- FTL Mesh, Surgical, Polymeric 2
- PEK Spinous Process Plate 2
- KWP Appliance, Fixation, Spinal Interlaminal 2
- PDQ Neurosurgical Nerve Locator 2
- BXM Stimulator, Nerve, Ac-Powered 2
- HRX Arthroscope 2
- FST Light, Surgical, Fiberoptic 1
- MQV Filler, Bone Void, Calcium Compound 1
- EZX Mesh, Surgical, Metal 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K233706 | Bendini Cloud ApplicationOLO · Traditional | 08/02/2024SE |
| K240507 | NuVasive AttraX ScaffoldMQV · Special | 03/20/2024SE |
| K223731 | NuVasive Modulus-C Interbody SystemODP · Special | 01/12/2023SE |
| K211757 | Simplify DiscQLQ · Traditional | 08/20/2021SE |
| K173117 | NuVasive® VersaTie SystemOWI · Traditional | 12/07/2017SE |
| K141665 | NuVasive CoRoent SystemMAX · Traditional | 03/13/2015SE |
| K142205 | NuVasive X-CORE(R) Expandable VBR SystemMQP · Traditional | 02/20/2015SE |
| K141968 | Nuvasive NVM5 SystemPDQ · Traditional | 11/14/2014SE |
| K140319 | Coroent Ti-C SystemMAX · Traditional | 10/09/2014SE |
| K140162 | Ap Expandable Xlif SystemMAX · Traditional | 07/02/2014SE |
| K140003 | Coroent Small Interbody SystemODP · Traditional | 04/03/2014SE |
| K133052 | Affix(R) Next Gen Spinous Process Plate SystemPEK · Traditional | 12/20/2013SE |
| K131025 | Archon Anterior Cervical Plate SystemKWQ · Traditional | 11/27/2013SE |
| K132014 | GSB Global Spinal Balance SystemNKB · Traditional | 10/31/2013SE |
| K131723 | Coroent Single Tab SystemOVD · Traditional | 09/20/2013SE |
| K130868 | Nuvasive Decade Lateral Plate SystemKWQ · Traditional | 08/29/2013SE |
| K131238 | Affix Spinous Process Plate SystemPEK · Traditional | 07/02/2013SE |
| K123307 | Nuvasive NVM5 SystemPDQ · Traditional | 04/23/2013SE |
| K123045 | Brigade Standalone SystemOVD · Special | 04/16/2013SE |
| K122081 | Nuvasive Long Lateral Spinal SystemKWQ · Special | 02/01/2013SE |
| K122742 | Nuvasive Bendini Spinal Rod Bending SystemOLO · Special | 12/07/2012SE |
| K121815 | Nuvasive Sage Lateral Plate SystemKWQ · Traditional | 10/23/2012SE |
| K122352 | Nuvasive Precept Spinal SystemNKB · Traditional | 09/11/2012SE |
| K121619 | Nuvasive Polyaxial Spinal ScrewsNKB · Special | 08/24/2012SE |
| K121837 | Nuvasive Brigade Anterior Plate SystemKWQ · Special | 07/16/2012SE |
| K120918 | Nuvasive Coroent Titanium SystemMAX · Traditional | 06/28/2012SE |
| K112717 | Nuvasive Nvjjb SystemETN · Traditional | 04/13/2012SE |
| K112718 | Nuvasive NVM5 SystemETN · Traditional | 03/16/2012SE |
| K112561 | Nuvasive Coroent No-Profile SystemOVD · Special | 03/13/2012SE |
| K111811 | Bendini(Tm) Spinal Rod Bending SystemOLO · Traditional | 12/05/2011SE |
| K111597 | Disposable Stimulating ElectrodeETN · Traditional | 10/13/2011SE |
| K111866 | Nuvasive Anterior Lumbar Plate SystemKWQ · Special | 07/22/2011SE |
| K111410 | Nuvasive Long Lateral Spinal SystemKWQ · Special | 06/20/2011SE |
| K103750 | Nuvasive Traverse Plate SystemKWQ · Special | 03/03/2011SE |
| K102547 | Coroent Interlock SystemOVE · Traditional | 02/07/2011SE |
| K102514 | Nuvasive Spherx II -Mas Deformity Spinal SystemNKB · Special | 12/01/2010SE |
| K101284 | Facet Screw SystemMRW · Traditional | 07/15/2010SE |
| K093319 | Nuvasive Vuepoint Oct SystemKWP · Special | 06/23/2010SE |
| K100043 | Coroent XLR Standalone SystemOVD · Traditional | 06/16/2010SE |
| K094054 | Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeGWF · Special | 05/14/2010SE |
| K093804 | Nuvasive Helix Revolution Acp SystemKWQ · Special | 02/19/2010SE |
| K091623 | Laminoplasty Fixation SystemNQW · Traditional | 10/09/2009SE |
| K092287 | Nuvasive Spherx II - Pedicle Screw SystemNKB · Special | 10/06/2009SE |
| K091502 | Nuvasive Spherx II SystemNKB · Special | 07/22/2009SE |
| K090981 | Modification to: Nuvasive Spherx SystemNKB · Special | 07/02/2009SE |
| K090298 | Nuvasive Neuro Vision SystemGWF · Traditional | 06/08/2009SE |
| K091071 | Nuvasive Lateral Plate SystemKWQ · Special | 05/08/2009SE |
| K090176 | Nuvasive Adjustable Vertebral Body Replacement SystemMQP · Special | 04/27/2009SE |
| K083341 | Nuvasive Helix-T Acp SystemKWQ · Special | 03/20/2009SE |
| K081377 | Nuvasive Surgical Mesh SystemFTL · Special | 01/15/2009SE |
| K083028 | Modification to: Nuvasive Spherx II SystemNKB · Special | 11/13/2008SE |
| K082332 | Nuvasive Spherx SystemNKB · Special | 10/10/2008SE |
| K081611 | Nuvasive Coroent SystemODP · Traditional | 10/02/2008SE |
| K082070 | Nuvasive Lateral Plate SystemKWQ · Special | 09/24/2008SE |
| K073278 | Spinous Process Plate SystemKWP · Traditional | 03/28/2008SE |
| K073275 | Nuvasive Helix Mini Acp SystemKWQ · Special | 01/29/2008SE |
| K071795 | Nuvasive Coroent SystemMAX · Abbreviated | 12/04/2007SE |
| K072343 | Neurovision JJB SystemGWF · Traditional | 10/29/2007SE |
| K072339 | Nuvasive Anterior Lumbar Plate SystemKWQ · Special | 10/19/2007SE |
| K071329 | Nuvasive Helix Acp SystemKWQ · Special | 08/08/2007SE |
| K071435 | Nuvasive Oct SystemMNI · Traditional | 08/06/2007SE |
| K070148 | Graft Containment DeviceKWQ · Traditional | 07/31/2007SE |
| K070273 | Modification to Nuvasive Lateral Plate SystemKWQ · Special | 04/03/2007SE |
| K062765 | Modification to Nuvasive Neurovision JJB SystemGWF · Special | 01/24/2007SE |
| K062590 | Nuvasive ACP4 SystemKWQ · Special | 01/18/2007SE |
| K062317 | Modification to Nuvasive Spherx II SystemMNH · Special | 09/01/2006SE |
| K061789 | Lateral Plate SystemKWQ · Traditional | 08/10/2006SE |
| K061778 | Nuvasive Spherx II SystemMNH · Special | 07/18/2006SE |
| K053215 | Surgical Mesh SystemFTL · Traditional | 07/17/2006SE |
| K060225 | Nuvasive Spherx SystemMNH · Special | 04/12/2006SE |
| K053581 | Nuvasive Smartplate Gradient Plus SystemKWQ · Special | 02/17/2006SE |
| K052210 | Nuvasive Coroent Extensure SystemMQP · Special | 12/12/2005SE |
| K051718 | Nuvasive Neurovision JJB SystemETN · Traditional | 09/15/2005SE |
| K051384 | Modification to: Nuvasive Neurovision JJB SystemGWF · Special | 07/11/2005SE |
| K043405 | Nuvasive Coroent SystemMQP · Traditional | 02/07/2005SE |
| K042034 | Nuvasive Maxcess Light GuideFST · Traditional | 10/26/2004SE |
| K041447 | Nuvasive Anterior Cervical Plate SystemKWQ · Traditional | 08/16/2004SE |
| K033546 | Nuvasive Spinal SystemMNH · Traditional | 04/12/2004SE |
| K040543 | Nuvasive Neurovision JJB SystemETN · Special | 04/01/2004SE |
| K032476 | Nuvasive MeshMQP · Special | 11/13/2003SE |
| K032083 | Nuvasive Neurovision JJB SystemETN · Traditional | 10/24/2003SE |
| K032180 | Nuvasive Cement RestrictorJDK · Traditional | 10/07/2003SESU |
| K023319 | Nuvasive MashMQP · Traditional | 03/04/2003SE |
| K020853 | Nuvasive MeshEZX · Traditional | 06/13/2002SE |
| K020411 | Nuvasive Triad Facet Screw SystemMRW · Traditional | 03/12/2002SE |
| K013257 | Hemi-Arc Surgical NavigatorHAW · Special | 10/30/2001SE |
| K013215 | Modified INS-1 Intraoperative Nerve Surveillance SystemBXM · Special | 10/16/2001SE |
| K002677 | Nuvasive INS-1 Intraoperative Nerve Surveillance SystemBXM · Traditional | 11/13/2000SE |
| K001323 | Nuvasive Percutaneous Transfacet/Intrapedicular ScrewMRW · Traditional | 07/25/2000SE |
| K994308 | Nuvasive Townley Facet ScrewMRW · Traditional | 04/18/2000SE |
| K992782 | Nuvasive Spinal Arthroscope, Models 0, 30 and 70 DegreesHRX · Traditional | 10/05/1999SE |
| K990324 | Nuvasive Guided Spinal Arthroscopy SystemHRX · Traditional | 10/05/1999SE |
PMA approvals
- P100012 Nuvasive PCM Cervical Disc System · 10/26/2012 · 7 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0738-2023 Class II | X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with…Potential that insert will be unable to disengage from the vertebral body replacement device/implant | 11/10/2022Open, Classified |
| Z-1052-2023 Class III | NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US…Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal… | 07/19/2022Open, Classified |
| Z-1453-2022 Class II | Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6…Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item… | 06/20/2022Open, Classified |
| Z-2684-2020 Class II | Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633…The NVM5 EMG Module kit intended for intraoperative neurophysiologic monitoring during spinal surgery… | 06/10/2020Terminated |
| Z-1898-2020 Class II | NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usage:…Post-implantation separation of an actuator end cap component that may expose internal components of the… | 02/13/2020Terminated |
| Z-0378-2013 Class II | 7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0377-2013 Class II | 7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0376-2013 Class II | 7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0375-2013 Class II | 6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0374-2013 Class II | 6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0373-2013 Class II | 6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0372-2013 Class II | 5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0371-2013 Class II | 5.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0370-2013 Class II | 5.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0369-2013 Class II | 4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0368-2013 Class II | 4.5mm x 35mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0367-2013 Class II | Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0366-2013 Class II | 7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0365-2013 Class II | 7.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0364-2013 Class II | 7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0363-2013 Class II | 7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0362-2013 Class II | 7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0361-2013 Class II | 7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0360-2013 Class II | 6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0359-2013 Class II | 6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0358-2013 Class II | 6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0357-2013 Class II | 6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0356-2013 Class II | 6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0355-2013 Class II | 6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0354-2013 Class II | 5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0353-2013 Class II | 5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0352-2013 Class II | 5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0351-2013 Class II | 5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0350-2013 Class II | 5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0349-2013 Class II | 5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |
| Z-0348-2013 Class II | Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNIThe tulip portion of the screw assembly can disengage from the shank after implantation. | 01/05/2009Terminated |