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Nuvasive, Inc.

United States·US-MF-000007421

Last updated September 17, 2026

Information

Country
United States
Address
7475, Lusk Blvd, San Diego, United States
LinkedIn
—
Facebook
—
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 7 of 500
DeviceModel / ReferenceRegistriesClassStatus
CoRoent 6716920
FDA UDI
Class IIActive
CoRoent 6421250
FDA UDI
Class IIActive
Alif 6956887
FDA UDI
Class IIActive
CoRoent 6777214
FDA UDI
Class IIActive
CoRoent 5334352P2
FDA UDI
Class IIActive
ReLine 16185565
FDA UDI
Class IIActive
CoRoent 5154342
FDA UDI
Class IIActive
ReLine 13119545
FDA UDI
Class IIActive
CoRoent 5122400
FDA UDI
Class IIActive
ReLine 3955520
FDA UDI
Class IIActive
CoRoent 5219328P2
FDA UDI
Class IIActive
CoRoent 5291402P2
FDA UDI
Class IIActive
CoRoent 5283365P2
FDA UDI
Class IIActive
CoRoent 6212050CP2
FDA UDI
Class IIActive
CoRoent 6771607CP2
FDA UDI
Class IIActive
Modulus ALP3DXLIFPRE
FDA UDI
Class IIActive
CoRoent 1713665
FDA UDI
Class IIActive
ReLine 13116545
FDA UDI
Class IIActive
CoRoent 5111404
FDA UDI
Class IIActive
CoRoent 5282304
FDA UDI
Class IIActive
CoRoent 5241340
FDA UDI
Class IIActive
ReLine 13011245
FDA UDI
Class IIActive
ReLine 15355290
FDA UDI
Class IIActive
Armada 7451331
FDA UDI
Class IIActive
CoRoent 6841036
FDA UDI
Class IIActive
CoRoent 6811130
FDA UDI
Class IIActive
CoRoent 6808815
FDA UDI
Class IIActive
ReLine 12160055
FDA UDI
Class IIActive
ReLine 11039590
FDA UDI
Class IIActive
ReLine 13354540P
FDA UDI
Class IIActive
ReLine 24039080
FDA UDI
Class IIActive
Modulus ALPCRVMDLUSIMP1
FDA UDI
Class IIActive
CoRoent 5141368P2
FDA UDI
Class IIActive
ReLine 14556070
FDA UDI
Class IIActive
ReLine 14511070
FDA UDI
Class IIActive
CoRoent 5264328
FDA UDI
Class IIActive
Nvm5 1615960
FDA UDI
Class IIActive
ReLine 10000410
FDA UDI
Class IActive
CoRoent 5129340P2
FDA UDI
Class IIActive
PEEK Corpectomy 5971418
FDA UDI
Class IIActive
ReLine 3813540
FDA UDI
Class IIActive
CoRoent 6734207
FDA UDI
Class IIActive
CoRoent CRXL60
FDA UDI
Class IIActive
SpheRx 7246550
FDA UDI
Class IIActive
Armada 8854545
FDA UDI
Class IIActive
CoRoent 6840610
FDA UDI
Class IIActive
CoRoent 6780314
FDA UDI
Class IIActive
CoRoent 6081428
FDA UDI
Class IIActive
Armada 8375550
FDA UDI
Class IIActive
ReLine 11021270
FDA UDI
Class IIActive

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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.

DateRecall No.ClassStatusReason
Nov 10, 2022Z-0738-2023—open, classified

Potential that insert will be unable to disengage from the vertebral body replacement device/implant

Jul 19, 2022Z-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, 2022Z-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, 2020Z-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, 2020Z-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, 2009Z-0369-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0361-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0351-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0370-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0375-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0348-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0354-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0377-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0355-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0374-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0378-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0352-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0372-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0363-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0350-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0364-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0367-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0359-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0366-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0373-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0362-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0349-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0360-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0353-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0365-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0376-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0371-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0357-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0358-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0368-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.

Jan 5, 2009Z-0356-2013—terminated

The tulip portion of the screw assembly can disengage from the shank after implantation.