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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 2 of 500
DeviceModel / ReferenceRegistriesClassStatus
ReLine 11082595
FDA UDI
Class IIActive
ReLine 24026080
FDA UDI
Class IIActive
CoRoent 6908250P
FDA UDI
Class IIActive
Archon 8780217
FDA UDI
Class IIActive
Nvm5 1566750
FDA UDI
Class IIActive
ReLine 3749411
FDA UDI
Class IIActive
Armada 8058580
FDA UDI
Class IIActive
Mas Plif 7070305
FDA UDI
Class IIActive
ReLine 10079535
FDA UDI
Class IIActive
ReLine 13385550P
FDA UDI
Class IIActive
ReLine 3714050
FDA UDI
Class IIActive
ReLine 24450115P
FDA UDI
Class IActive
ReLine 3735556
FDA UDI
Class IIActive
ReLine 16177040
FDA UDI
Class IIActive
Cohere 1931345
FDA UDI
Class IActive
NuVasive Z200041-016
FDA UDI
Class IIActive
CoRoent 6981045P
FDA UDI
Class IIActive
MaXcess 1575829
FDA UDI
Class IActive
VuePoint 8976356
FDA UDI
Class IIActive
ReLine 16215570
FDA UDI
Class IIActive
CoRoent 5259362P2
FDA UDI
Class IIActive
VuePoint 8980524P3
FDA UDI
Class IIActive
CoRoent 5330408P2
FDA UDI
Class IIActive
CoRoent 1713688
FDA UDI
Class IIActive
CoRoent 5104345
FDA UDI
Class IIActive
CoRoent 5314308
FDA UDI
Class IIActive
ReLine 12460040
FDA UDI
Class IIActive
CoRoent 1694961
FDA UDI
Class IIActive
CoRoent 6916855
FDA UDI
Class IIActive
CoRoent 5131364
FDA UDI
Class IIActive
ReLine 13065512
FDA UDI
Class IIActive
CoRoent 6970662
FDA UDI
Class IActive
CoRoent 5299284P2
FDA UDI
Class IIActive
Xlif 1781930
FDA UDI
Class IActive
CoRoent 5281340
FDA UDI
Class IIActive
ReLine 13110555
FDA UDI
Class IIActive
CoRoent 5195104
FDA UDI
Class IIActive
ReLine 16027590
FDA UDI
Class IIActive
Brigade 7502129
FDA UDI
Class IIActive
CoRoent 6813312
FDA UDI
Class IIActive
ReLine 14155055
FDA UDI
Class IIActive
ReLine 11039510
FDA UDI
Class IIActive
CoRoent 6910215
FDA UDI
Class IIActive
Modulus 1221260P2
FDA UDI
Class IIActive
CoRoent 5434402
FDA UDI
Class IIActive
CoRoent 5424304
FDA UDI
Class IIActive
CoRoent 6790831
FDA UDI
Class IActive
Tlx 1742685
FDA UDI
Class IIActive
CoRoent 5184360
FDA UDI
Class IIActive
ReLine 16081180
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.