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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 15 of 500
DeviceModel / ReferenceRegistriesClassStatus
VuePoint 8980430P
FDA UDI
Class IIActive
CoRoent 5123408P2
FDA UDI
Class IIActive
ReLine 3974540
FDA UDI
Class IIActive
ReLine 10000415
FDA UDI
Class IActive
Archon 8882362
FDA UDI
Class IIActive
ReLine 10011125
FDA UDI
Class IIActive
Precept 8847025P
FDA UDI
Class IIActive
MaXcess 1006769
FDA UDI
Class IActive
ReLine 3835525
FDA UDI
Class IIActive
ReLine 10100106
FDA UDI
Class IIActive
ReLine 16384535P
FDA UDI
Class IIActive
ReLine 14619080
FDA UDI
Class IIActive
CoRoent 5484405
FDA UDI
Class IIActive
Base 6959195
FDA UDI
Class IIActive
MaXcess D3500005
FDA UDI
Class IActive
CoRoent 5363015
FDA UDI
Class IIActive
CoRoent 5390250
FDA UDI
Class IIActive
ReLine 16011285
FDA UDI
Class IIActive
Armada 8744535
FDA UDI
Class IIActive
ReLine 11360190
FDA UDI
Class IIActive
CoRoent 6710126
FDA UDI
Class IIActive
Archon 8881218
FDA UDI
Class IIActive
ReLine 15155250
FDA UDI
Class IIActive
ReLine 11250045
FDA UDI
Class IIActive
ReLine 11028545
FDA UDI
Class IIActive
Mas Plif MASPLIFFIXINS
FDA UDI
Class IIActive
Archon 8881222
FDA UDI
Class IIActive
ReLine 24350050
FDA UDI
Class IActive
NuVasive Z700147-11
FDA UDI
Class IActive
ReLine 24039510
FDA UDI
Class IIActive
ReLine ALPRELONEIN
FDA UDI
Class IIActive
ReLine 24024520
FDA UDI
Class IIActive
ReLine 3960420
FDA UDI
Class IIActive
CoRoent 5169325P2
FDA UDI
Class IIActive
ReLine 21547055
FDA UDI
Class IIActive
Pulse BETPULSELRTABLET
FDA UDI
Class IIActive
Modulus Expandable 1980852
FDA UDI
Class IActive
ReLine 3786538
FDA UDI
Class IIActive
ReLine 13550000P
FDA UDI
Class IIActive
CoRoent 5111325
FDA UDI
Class IIActive
CoRoent 5312515P2
FDA UDI
Class IIActive
ReLine 10000439
FDA UDI
Class IIActive
Precept 8881030
FDA UDI
Class IIActive
ReLine 11085585
FDA UDI
Class IIActive
Helix 7735113
FDA UDI
Class IIActive
ReLine 11060200
FDA UDI
Class IIActive
NuVasive 1538324
FDA UDI
Class IActive
ReLine 13325030P
FDA UDI
Class IIActive
ReLine 11001297
FDA UDI
Class IActive
Armada 8552445
FDA UDI
Class IIActive

Related Companies

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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.