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Sign in to claim this brandNuvasive, Inc.
United States·US-MF-000007421
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 7475, Lusk Blvd, San Diego, United States
- Website
- https://www.globusmedical.com
- —
- —
- [email protected]
- Phone
- +1-858-909-1800
- PRRC Contact
- Daniel S. Paul
- EUDAMED SRN
- US-MF-000007421
- FDA FEI Number
- 3002980729
- DUNS Number
- 053950783
Catalogue (44291)
Page 1 of 500| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ReLine | 14555527 | FDA UDI | Class II | Active |
| CoRoent | 5133408 | FDA UDI | Class II | Active |
| Base | 6959053 | FDA UDI | Class II | Active |
| ReLine | 12355540 | FDA UDI | Class II | Active |
| Precept | 8888590 | FDA UDI | Class II | Active |
| Xlif | 6940012 | FDA UDI | Class I | Active |
| ReLine | 11085080 | FDA UDI | Class II | Active |
| Tlif | 1010700 | FDA UDI | Class I | Active |
| ReLine | 13315545P | FDA UDI | Class II | Active |
| ReLine | 14511175 | FDA UDI | Class II | Active |
| ReLine | 10200111 | FDA UDI | Class II | Active |
| ReLine | 16118025 | FDA UDI | Class II | Active |
| Precept | 8897040 | FDA UDI | Class II | Active |
| ReLine | 13178045 | FDA UDI | Class II | Active |
| ReLine | 15250520 | FDA UDI | Class II | Active |
| Archon | 8881417 | FDA UDI | Class II | Active |
| CoRoent | 6251112 | FDA UDI | Class I | Active |
| CoRoent | 6421650 | FDA UDI | Class II | Active |
| NuVasive | 5035214 | FDA UDI | Class I | Active |
| ReLine | 16185555P | FDA UDI | Class II | Active |
| Acp | 8786131 | FDA UDI | Class II | Active |
| CoRoent | 6981450P | FDA UDI | Class II | Active |
| ReLine | 3700321 | FDA UDI | Class II | Active |
| Pulse | 1830010 | FDA UDI | Class II | Active |
| CoRoent | 6850810P2 | FDA UDI | Class II | Active |
| MaXcess | 3500031 | FDA UDI | Class I | Active |
| CoRoent | 6131428 | FDA UDI | Class II | Active |
| CoRoent | 5264400 | FDA UDI | Class II | Active |
| ReLine | 16114525 | FDA UDI | Class II | Active |
| CoRoent | 5220284 | FDA UDI | Class II | Active |
| CoRoent | 5202348 | FDA UDI | Class II | Active |
| ReLine | 16084535 | FDA UDI | Class II | Active |
| ReLine | 15255340 | FDA UDI | Class II | Active |
| CoRoent | 5159300P2 | FDA UDI | Class II | Active |
| ReLine | 14586540 | FDA UDI | Class II | Active |
| ReLine | 14584535 | FDA UDI | Class II | Active |
| VuePoint | 8973575P | FDA UDI | Class II | Active |
| ReLine | 12101390 | FDA UDI | Class II | Active |
| ReLine | 14511250 | FDA UDI | Class II | Active |
| ReLine | 15455045 | FDA UDI | Class II | Active |
| ReLine | 16178090 | FDA UDI | Class II | Active |
| ReLine | 16115085 | FDA UDI | Class II | Active |
| ReLine | 15260220 | FDA UDI | Class II | Active |
| Brigade | 1903508 | FDA UDI | Class II | Active |
| ReLine | 14554590 | FDA UDI | Class II | Active |
| ReLine | 15450180 | FDA UDI | Class II | Active |
| ReLine | 12460390 | FDA UDI | Class II | Active |
| CoRoent | 5320400 | FDA UDI | Class II | Active |
| Helix | 7800356 | FDA UDI | Class II | Active |
| ReLine | 10011130 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
Importers
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Notified Bodies
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Authorities
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FDA Recalls (36)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Nov 10, 2022 | Z-0738-2023 | — | open, classified | Potential that insert will be unable to disengage from the vertebral body replacement device/implant |
| Jul 19, 2022 | Z-1052-2023 | — | open, classified | 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. |
| Jun 20, 2022 | Z-1453-2022 | — | open, classified | 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. |
| Jun 10, 2020 | Z-2684-2020 | — | terminated | 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. |
| Feb 13, 2020 | Z-1898-2020 | — | terminated | 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. |
| Jan 5, 2009 | Z-0369-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0361-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0351-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0370-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0375-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0348-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0354-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0377-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0355-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0374-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0378-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0352-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0372-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0363-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0350-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0364-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0367-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0359-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0366-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0373-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0362-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0349-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0360-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0353-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0365-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0376-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0371-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0357-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0358-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0368-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |
| Jan 5, 2009 | Z-0356-2013 | — | terminated | The tulip portion of the screw assembly can disengage from the shank after implantation. |