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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 8 of 500
DeviceModel / ReferenceRegistriesClassStatus
Halo 7892044
FDA UDI
Class IIActive
NuVasive Z200221-208
FDA UDI
Class IIActive
CoRoent 5259302
FDA UDI
Class IIActive
VuePoint VUEOCC
FDA UDI
Class IIActive
ReLine 10078590
FDA UDI
Class IIActive
ReLine 24036595
FDA UDI
Class IIActive
Pulse LNPULSEDRILLGUIDE
FDA UDI
Class IIActive
ReLine 3836036
FDA UDI
Class IIActive
ReLine 20345110
FDA UDI
Class IIActive
MaXcess 3500104
FDA UDI
Class IActive
Apx 1672356
FDA UDI
Class IIActive
Mas Plif 7242100
FDA UDI
Class IIActive
ReLine 11021112
FDA UDI
Class IIActive
VuePoint 8980010P
FDA UDI
Class IIActive
ReLine 3996003
FDA UDI
Class IIActive
Modulus 1265884
FDA UDI
Class IIActive
ReLine 15250110
FDA UDI
Class IIActive
ReLine 11030580
FDA UDI
Class IIActive
X-Core 7180079
FDA UDI
Class IIActive
Acp 18009114
FDA UDI
Class IIActive
Modulus 1265938
FDA UDI
Class IIActive
CoRoent 5250285P2
FDA UDI
Class IIActive
CoRoent 1713723
FDA UDI
Class IIActive
CoRoent 5342515P2
FDA UDI
Class IIActive
CoRoent 5211285
FDA UDI
Class IIActive
ReLine 14455070
FDA UDI
Class IIActive
Gradient 7450250
FDA UDI
Class IIActive
ReLine 13315040P
FDA UDI
Class IIActive
CoRoent 6777010
FDA UDI
Class IIActive
Alif 6956994
FDA UDI
Class IIActive
CoRoent 5354350P2
FDA UDI
Class IIActive
ReLine 13055545A
FDA UDI
Class IIActive
CoRoent 5122342
FDA UDI
Class IIActive
ReLine 13170565
FDA UDI
Class IIActive
CoRoent 5350252
FDA UDI
Class IIActive
ReLine 10000233
FDA UDI
Class IActive
SpheRx 7236350
FDA UDI
Class IIActive
Precept 8896525
FDA UDI
Class IIActive
ReLine 15260100
FDA UDI
Class IIActive
SpheRx 7237775
FDA UDI
Class IIActive
CoRoent 5324250P2
FDA UDI
Class IIActive
Brigade 7502136
FDA UDI
Class IIActive
X-Core 6539027
FDA UDI
Class IIActive
Modulus 1982184
FDA UDI
Class IActive
ReLine 24037530
FDA UDI
Class IIActive
CoRoent 5374350P2
FDA UDI
Class IIActive
CoRoent 1713669
FDA UDI
Class IIActive
ReLine 16189065
FDA UDI
Class IIActive
ReLine 10000945
FDA UDI
Class IIActive
Tlx 1742612
FDA UDI
Class IIActive

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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.