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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 20 of 500
DeviceModel / ReferenceRegistriesClassStatus
CoRoent 5254308P2
FDA UDI
Class IIActive
CoRoent 5242345P2
FDA UDI
Class IIActive
ReLine 13116025
FDA UDI
Class IIActive
ReLine 14521045
FDA UDI
Class IIActive
CoRoent 6912245P2
FDA UDI
Class IIActive
CoRoent 5239340
FDA UDI
Class IIActive
Nvm5 1616240
FDA UDI
Class IIActive
CoRoent 7221060
FDA UDI
Class IIActive
SpheRx 7755540
FDA UDI
Class IIActive
CoRoent 7161665
FDA UDI
Class IIActive
ReLine 13038080
FDA UDI
Class IIActive
ReLine 10055340
FDA UDI
Class IIActive
Armada 7451110
FDA UDI
Class IActive
MaXcess 3231050
FDA UDI
Class IActive
ReLine 14525520
FDA UDI
Class IIActive
CoRoent 5101308P2
FDA UDI
Class IIActive
CoRoent 5254280P2
FDA UDI
Class IIActive
SpheRx 7246590
FDA UDI
Class IIActive
ReLine 10100516
FDA UDI
Class IIActive
ReLine 11020575
FDA UDI
Class IIActive
ReLine 10078040
FDA UDI
Class IIActive
VuePoint 8980524P
FDA UDI
Class IIActive
NuVasive Z700221-07
FDA UDI
Class IIActive
CoRoent 5121328P2
FDA UDI
Class IIActive
CoRoent 5191280P2
FDA UDI
Class IIActive
NuVasive Z700224-12
FDA UDI
Class IActive
CoRoent 5169288P2
FDA UDI
Class IIActive
ReLine 3786530
FDA UDI
Class IIActive
ReLine 13085565
FDA UDI
Class IIActive
ReLine 13029011
FDA UDI
Class IIActive
ReLine 11350105
FDA UDI
Class IIActive
ReLine 10000409
FDA UDI
Class IActive
Mlx 1620702
FDA UDI
Class IActive
CoRoent 1661761
FDA UDI
Class IIActive
ReLine 14055070
FDA UDI
Class IIActive
ReLine 3990012
FDA UDI
Class IActive
ReLine 3824022
FDA UDI
Class IIActive
Pulse PULSELRGE9
FDA UDI
Class IIActive
ReLine 24031055
FDA UDI
Class IIActive
CoRoent 5364308
FDA UDI
Class IIActive
Brigade 1604977
FDA UDI
Class IActive
Armada 8437570
FDA UDI
Class IIActive
ReLine 11089090
FDA UDI
Class IIActive
NuVasive Z700161-208
FDA UDI
Class IActive
CoRoent 5293345P2
FDA UDI
Class IIActive
CoRoent 5222320P2
FDA UDI
Class IIActive
CoRoent 6779015CP2
FDA UDI
Class IIActive
CoRoent 5293405
FDA UDI
Class IIActive
Archon 8881122
FDA UDI
Class IIActive
MaXcess 3405040
FDA UDI
Class IActive

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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.