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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 1 of 500
DeviceModel / ReferenceRegistriesClassStatus
ReLine 14555527
FDA UDI
Class IIActive
CoRoent 5133408
FDA UDI
Class IIActive
Base 6959053
FDA UDI
Class IIActive
ReLine 12355540
FDA UDI
Class IIActive
Precept 8888590
FDA UDI
Class IIActive
Xlif 6940012
FDA UDI
Class IActive
ReLine 11085080
FDA UDI
Class IIActive
Tlif 1010700
FDA UDI
Class IActive
ReLine 13315545P
FDA UDI
Class IIActive
ReLine 14511175
FDA UDI
Class IIActive
ReLine 10200111
FDA UDI
Class IIActive
ReLine 16118025
FDA UDI
Class IIActive
Precept 8897040
FDA UDI
Class IIActive
ReLine 13178045
FDA UDI
Class IIActive
ReLine 15250520
FDA UDI
Class IIActive
Archon 8881417
FDA UDI
Class IIActive
CoRoent 6251112
FDA UDI
Class IActive
CoRoent 6421650
FDA UDI
Class IIActive
NuVasive 5035214
FDA UDI
Class IActive
ReLine 16185555P
FDA UDI
Class IIActive
Acp 8786131
FDA UDI
Class IIActive
CoRoent 6981450P
FDA UDI
Class IIActive
ReLine 3700321
FDA UDI
Class IIActive
Pulse 1830010
FDA UDI
Class IIActive
CoRoent 6850810P2
FDA UDI
Class IIActive
MaXcess 3500031
FDA UDI
Class IActive
CoRoent 6131428
FDA UDI
Class IIActive
CoRoent 5264400
FDA UDI
Class IIActive
ReLine 16114525
FDA UDI
Class IIActive
CoRoent 5220284
FDA UDI
Class IIActive
CoRoent 5202348
FDA UDI
Class IIActive
ReLine 16084535
FDA UDI
Class IIActive
ReLine 15255340
FDA UDI
Class IIActive
CoRoent 5159300P2
FDA UDI
Class IIActive
ReLine 14586540
FDA UDI
Class IIActive
ReLine 14584535
FDA UDI
Class IIActive
VuePoint 8973575P
FDA UDI
Class IIActive
ReLine 12101390
FDA UDI
Class IIActive
ReLine 14511250
FDA UDI
Class IIActive
ReLine 15455045
FDA UDI
Class IIActive
ReLine 16178090
FDA UDI
Class IIActive
ReLine 16115085
FDA UDI
Class IIActive
ReLine 15260220
FDA UDI
Class IIActive
Brigade 1903508
FDA UDI
Class IIActive
ReLine 14554590
FDA UDI
Class IIActive
ReLine 15450180
FDA UDI
Class IIActive
ReLine 12460390
FDA UDI
Class IIActive
CoRoent 5320400
FDA UDI
Class IIActive
Helix 7800356
FDA UDI
Class IIActive
ReLine 10011130
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.