Company · US
Nuvasive, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2024. Name variants (Inc, Corp, punctuation) are merged.
92510(k) clearances (0 in 12 months)
36recalls (0 in 12 months)
35recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 40 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 21 |
| MQP | Spinal Vertebral Body Replacement Device | 7 |
| ETN | Stimulator, Nerve | 6 |
| GWF | Stimulator, Electrical, Evoked Response | 5 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 5 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 4 |
| MRW | System, Facet Screw Spinal Device | 4 |
| OLO | Orthopedic Stereotaxic Instrument | 4 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 4 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 3 |
| PDQ | Neurosurgical Nerve Locator | 3 |
| BXM | Stimulator, Nerve, Ac-Powered | 2 |
| FTL | Mesh, Surgical, Polymeric | 2 |
| HRX | Arthroscope | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 2 |
| PEK | Spinous Process Plate | 2 |
| EZX | Mesh, Surgical, Metal | 1 |
| FST | Light, Surgical, Fiberoptic | 1 |
| HAW | Neurological Stereotaxic Instrument | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 2, 2024 | K233706 | Bendini Cloud Application Nuvasive | OLO |
| Mar 20, 2024 | K240507 | NuVasive AttraX Scaffold Nuvasive, Inc. | MQV |
| Jan 12, 2023 | K223731 | NuVasive Modulus-C Interbody System Nuvasive, Inc. | ODP |
| Aug 20, 2021 | K211757 | Simplify Disc Nuvasive, Inc. | QLQ |
| Dec 7, 2017 | K173117 | NuVasive® VersaTie System Nuvasive, Inc. | OWI |
| Mar 13, 2015 | K141665 | NuVasive CoRoent System Nuvasive, Inc. | MAX |
| Feb 20, 2015 | K142205 | NuVasive X-CORE(R) Expandable VBR System Nuvasive, Inc. | MQP |
| Nov 14, 2014 | K141968 | NUVASIVE NVM5 SYSTEM Nuvasive, Inc. | PDQ |
| Oct 9, 2014 | K140319 | COROENT TI-C SYSTEM Nuvasive, Inc. | MAX |
| Jul 2, 2014 | K140162 | AP EXPANDABLE XLIF SYSTEM Nuvasive, Inc. | MAX |
| Apr 3, 2014 | K140003 | COROENT SMALL INTERBODY SYSTEM Nuvasive, Inc. | ODP |
| Dec 20, 2013 | K133052 | AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM Nuvasive, Inc. | PEK |
| Nov 27, 2013 | K131025 | ARCHON ANTERIOR CERVICAL PLATE SYSTEM Nuvasive, Inc. | KWQ |
| Oct 31, 2013 | K132014 | GSB GLOBAL SPINAL BALANCE SYSTEM Nuvasive, Inc. | NKB |
| Sep 20, 2013 | K131723 | COROENT SINGLE TAB SYSTEM Nuvasive, Inc. | OVD |
| Aug 29, 2013 | K130868 | NUVASIVE DECADE LATERAL PLATE SYSTEM Nuvasive, Inc. | KWQ |
| Jul 2, 2013 | K131238 | AFFIX SPINOUS PROCESS PLATE SYSTEM Nuvasive, Inc. | PEK |
| Apr 23, 2013 | K123307 | NUVASIVE NVM5 SYSTEM Nuvasive, Inc. | PDQ |
| Apr 16, 2013 | K123045 | BRIGADE STANDALONE SYSTEM Nuvasive, Inc. | OVD |
| Feb 1, 2013 | K122081 | NUVASIVE LONG LATERAL SPINAL SYSTEM Nuvasive, Inc. | KWQ |
| Dec 7, 2012 | K122742 | NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM Nuvasive, Inc. | OLO |
| Oct 23, 2012 | K121815 | NUVASIVE SAGE LATERAL PLATE SYSTEM Nuvasive, Inc. | KWQ |
| Sep 11, 2012 | K122352 | NUVASIVE PRECEPT SPINAL SYSTEM Nuvasive, Inc. | NKB |
| Aug 24, 2012 | K121619 | NUVASIVE POLYAXIAL SPINAL SCREWS Nuvasive, Inc. | NKB |
| Jul 16, 2012 | K121837 | NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM Nuvasive, Inc. | KWQ |
| Jun 28, 2012 | K120918 | NUVASIVE COROENT TITANIUM SYSTEM Nuvasive, Inc. | MAX |
| Apr 13, 2012 | K112717 | NUVASIVE NVJJB SYSTEM Nuvasive, Inc. | ETN |
| Mar 16, 2012 | K112718 | NUVASIVE NVM5 SYSTEM Nuvasive, Inc. | ETN |
| Mar 13, 2012 | K112561 | NUVASIVE COROENT NO-PROFILE SYSTEM Nuvasive, Inc. | OVD |
| Dec 5, 2011 | K111811 | BENDINI(TM) SPINAL ROD BENDING SYSTEM Nuvasive, Inc. | OLO |
| Oct 13, 2011 | K111597 | DISPOSABLE STIMULATING ELECTRODE Nuvasive, Inc. | ETN |
| Jul 22, 2011 | K111866 | NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM Nuvasive, Inc. | KWQ |
| Jun 20, 2011 | K111410 | NUVASIVE LONG LATERAL SPINAL SYSTEM Nuvasive, Inc. | KWQ |
| Mar 3, 2011 | K103750 | NUVASIVE TRAVERSE PLATE SYSTEM Nuvasive, Inc. | KWQ |
| Feb 7, 2011 | K102547 | COROENT INTERLOCK SYSTEM Nuvasive, Inc. | OVE |
| Dec 1, 2010 | K102514 | NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM Nuvasive, Inc. | NKB |
| Jul 15, 2010 | K101284 | FACET SCREW SYSTEM Nuvasive, Inc. | MRW |
| Jun 23, 2010 | K093319 | NUVASIVE VUEPOINT OCT SYSTEM Nuvasive, Inc. | KWP |
| Jun 16, 2010 | K100043 | COROENT XLR STANDALONE SYSTEM Nuvasive, Inc. | OVD |
| May 14, 2010 | K094054 | MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE Nuvasive, Inc. | GWF |
| Feb 19, 2010 | K093804 | NUVASIVE HELIX REVOLUTION ACP SYSTEM Nuvasive, Inc. | KWQ |
| Oct 9, 2009 | K091623 | LAMINOPLASTY FIXATION SYSTEM Nuvasive, Inc. | NQW |
| Oct 6, 2009 | K092287 | NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM Nuvasive, Inc. | NKB |
| Jul 22, 2009 | K091502 | NUVASIVE SPHERX II SYSTEM Nuvasive, Inc. | NKB |
| Jul 2, 2009 | K090981 | MODIFICATION TO: NUVASIVE SPHERX SYSTEM Nuvasive, Inc. | NKB |
| Jun 8, 2009 | K090298 | NUVASIVE NEURO VISION SYSTEM Nuvasive, Inc. | GWF |
| May 8, 2009 | K091071 | NUVASIVE LATERAL PLATE SYSTEM Nuvasive, Inc. | KWQ |
| Apr 27, 2009 | K090176 | NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM Nuvasive, Inc. | MQP |
| Mar 20, 2009 | K083341 | NUVASIVE HELIX-T ACP SYSTEM Nuvasive, Inc. | KWQ |
| Jan 15, 2009 | K081377 | NUVASIVE SURGICAL MESH SYSTEM Nuvasive, Inc. | FTL |
Newest 50 of 92.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 3, 2023 | NuVasive Inc NuVasive MD Pulse III Multimodality System REF 1881500
Pulse Software version 369-BL.US and 369-BLN.US Open, Classified |
OLO | K210574 |
| Dec 20, 2022 | NuVasive Inc X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation. Open, Classified |
MQP | K090176 |
| Jun 20, 2022 | NuVasive Inc 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 Dis Open, Classified |
MJO | None listed |
| Jun 10, 2020 | NuVasive Inc Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery. Terminated |
PDQ | K143641 |
| Feb 13, 2020 | NuVasive Inc 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 Terminated |
PGN | K171791 |
| Nov 19, 2012 | NuVasive Inc 7.5mm x 50mm Noncannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 7.5mm x 45mm Noncannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 7.5mm x 40mm Noncannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 6.5mm x 50mm Noncannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 6.5mm x 45mm Noncannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 6.5mm x 40mm Noncannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 5.5mm x 50mm Noncannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 5.5mm x 45mm Noncannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 5.5mm x 40mm Noncannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 4.5mm x 40mm Noncannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 4.5mm x 35mm Noncannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc Screw Tulip , 5.5mm Rod
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 7.5mm x 55mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 7.5mm x 50mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 7.5mm x 45mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 7.5mm x 40mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 7.5mm x 35mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 7.5mm x 30mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 6.5mm x 55mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 6.5mm x 50mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 6.5mm x 45mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 6.5mm x 40mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 6.5mm x 35mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 6.5mm x 30mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 5.5mm x 55mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 5.5mm x 50mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 5.5mm x 45mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 5.5mm x 40mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 5.5mm x 35mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 5.5mm x 30mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc Screw Tulip , 6.25mm Rod
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |