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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 26 of 500
DeviceModel / ReferenceRegistriesClassStatus
CoRoent 5490355
FDA UDI
Class IIActive
CoRoent 5320400P2
FDA UDI
Class IIActive
ReLine 13057085
FDA UDI
Class IIActive
CoRoent 5250402
FDA UDI
Class IIActive
ReLine 16011575
FDA UDI
Class IIActive
ReLine 13054590A
FDA UDI
Class IIActive
CoRoent 6813130
FDA UDI
Class IIActive
Precept 8827535
FDA UDI
Class IIActive
ReLine 12255330
FDA UDI
Class IIActive
Pcm 7674100
FDA UDI
Class IActive
ReLine 14545555
FDA UDI
Class IIActive
CoRoent 5434250
FDA UDI
Class IIActive
ReLine 14522512
FDA UDI
Class IIActive
ReLine 10000959
FDA UDI
Class IActive
CoRoent 5300252
FDA UDI
Class IIActive
ReLine 12455150
FDA UDI
Class IIActive
CoRoent 5252284
FDA UDI
Class IIActive
ReLine 16021080
FDA UDI
Class IIActive
ReLine 16011025
FDA UDI
Class IIActive
ReLine 13021265
FDA UDI
Class IIActive
Ilif 5760212
FDA UDI
Class IActive
Mas Plif 7095550
FDA UDI
Class IIActive
FormaGraft 5010008
FDA UDI
Class IIActive
Gradient 7490238
FDA UDI
Class IIActive
CoRoent 6771630
FDA UDI
Class IIActive
CoRoent 5269282
FDA UDI
Class IIActive
SpheRx SPXPPSNC
FDA UDI
Class IIActive
ReLine 10000748
FDA UDI
Class IActive
Armada ARM55DEFIN2
FDA UDI
Class IIActive
Armada D7459107
FDA UDI
Class IIActive
ReLine 15350270
FDA UDI
Class IIActive
ReLine 11086070
FDA UDI
Class IIActive
ReLine 12350150
FDA UDI
Class IIActive
Armada 8634530
FDA UDI
Class IIActive
CoRoent 7083540
FDA UDI
Class IIActive
CoRoent 6807714
FDA UDI
Class IIActive
CoRoent 6711120
FDA UDI
Class IIActive
CoRoent 6708820
FDA UDI
Class IIActive
ReLine 15160400
FDA UDI
Class IIActive
Armada 8555045
FDA UDI
Class IIActive
ReLine 10018035
FDA UDI
Class IIActive
Brigade 6972139
FDA UDI
Class IIActive
CoRoent 5184348P2
FDA UDI
Class IIActive
NuVasive Z200069-112
FDA UDI
Class IIActive
CoRoent 6921450CP2
FDA UDI
Class IIActive
Mas Pcf 8941068
FDA UDI
Class IActive
ReLine 15055400
FDA UDI
Class IIActive
Mas Pcf 8945728
FDA UDI
Class IIActive
ReLine 11455050
FDA UDI
Class IIActive
ReLine 11044060
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.