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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 29 of 500
DeviceModel / ReferenceRegistriesClassStatus
CoRoent 6900931
FDA UDI
Class IActive
ReLine 3735524
FDA UDI
Class IIActive
VuePoint 8975630
FDA UDI
Class IIActive
CoRoent 5274400P2
FDA UDI
Class IIActive
ReLine 20545190
FDA UDI
Class IIActive
SpheRx 7377545
FDA UDI
Class IIActive
ReLine 17060001
FDA UDI
Class IIActive
CoRoent 1607887
FDA UDI
Class IActive
CoRoent 5211365
FDA UDI
Class IIActive
ReLine 16011050
FDA UDI
Class IIActive
Gradient 7450364
FDA UDI
Class IIActive
Armada 8745555
FDA UDI
Class IIActive
X-Core 5952243
FDA UDI
Class IIActive
ReLine 24012575
FDA UDI
Class IIActive
ReLine 24010525
FDA UDI
Class IIActive
Pulse 5050455
FDA UDI
Class IIActive
ReLine 3836558
FDA UDI
Class IIActive
Acp 18002598
FDA UDI
Class IIActive
CoRoent 5234320P2
FDA UDI
Class IIActive
ReLine 13184575
FDA UDI
Class IIActive
CoRoent 5112325
FDA UDI
Class IIActive
CoRoent 1640912
FDA UDI
Class IIActive
CoRoent 5324408
FDA UDI
Class IIActive
SpheRx 7100136
FDA UDI
Class IIActive
CoRoent 6800406
FDA UDI
Class IIActive
ReLine 15160110
FDA UDI
Class IIActive
Armada 8450350
FDA UDI
Class IIActive
Helix 7739313
FDA UDI
Class IIActive
ReLine 11017565
FDA UDI
Class IIActive
ReLine 3742025
FDA UDI
Class IIActive
ReLine 3745105
FDA UDI
Class IIActive
CoRoent 5239328
FDA UDI
Class IIActive
ReLine 13066575
FDA UDI
Class IIActive
ReLine 13017030
FDA UDI
Class IIActive
ReLine 11037530
FDA UDI
Class IIActive
ReLine 11026090
FDA UDI
Class IIActive
SpheRx 7755535
FDA UDI
Class IIActive
Helix 7747113
FDA UDI
Class IIActive
ReLine 3995008
FDA UDI
Class IActive
ReLine 3900241
FDA UDI
Class IIActive
ReLine 3737536
FDA UDI
Class IIActive
CoRoent 6509265CP2
FDA UDI
Class IIActive
Archon 8780811
FDA UDI
Class IIActive
ReLine 13115090
FDA UDI
Class IIActive
CoRoent 5141404
FDA UDI
Class IIActive
CoRoent 5131348
FDA UDI
Class IIActive
ReLine 16025575
FDA UDI
Class IIActive
ReLine 16021275
FDA UDI
Class IIActive
ReLine 13081512
FDA UDI
Class IIActive
ReLine 13015075
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.