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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
Website: https://www.globusmedical.com
LinkedIn: —
Facebook: —
Email: [email protected]
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 3 of 500

Device	Model / Reference	Registries	Class	Status
CoRoent	5120302P2	FDA UDI	Class II	Active
CoRoent	5112325P2	FDA UDI	Class II	Active
CoRoent	6981240	FDA UDI	Class II	Active
ReLine	10079595	FDA UDI	Class II	Active
ReLine	10000700	FDA UDI	Class I	Active
VuePoint	8975732	FDA UDI	Class II	Active
Armada	8646050	FDA UDI	Class II	Active
X-Core	6539060	FDA UDI	Class II	Active
ReLine	11089070	FDA UDI	Class II	Active
ReLine	10076080	FDA UDI	Class II	Active
ReLine	10100104	FDA UDI	Class II	Active
MaXcess	1579741	FDA UDI	Class I	Active
ReLine	10018510	FDA UDI	Class II	Active
MaXcess	1572760	FDA UDI	Class I	Active
Armada	7559132	FDA UDI	Class II	Active
ReLine	11360045P	FDA UDI	Class II	Active
ReLine	3923550	FDA UDI	Class II	Active
ReLine	13028511	FDA UDI	Class II	Active
Brigade	6983238	FDA UDI	Class II	Active
Brigade	6968513	FDA UDI	Class II	Active
ReLine	11001058	FDA UDI	Class II	Active
CoRoent	5110304P2	FDA UDI	Class II	Active
ReLine	14584512	FDA UDI	Class II	Active
ReLine	14517011	FDA UDI	Class II	Active
SpheRx	7766555	FDA UDI	Class II	Active
ReLine	11000717	FDA UDI	Class I	Active
ReLine	14486540P	FDA UDI	Class II	Active
MaXcess	1552629	FDA UDI	Class I	Active
ReLine	3775045	FDA UDI	Class II	Active
ReLine	3764010	FDA UDI	Class II	Active
Modulus	1982178	FDA UDI	Class I	Active
Armada	8566540	FDA UDI	Class II	Active
CoRoent	6981460P	FDA UDI	Class II	Active
CoRoent	7871445	FDA UDI	Class II	Active
MaXcess	1563448	FDA UDI	Class I	Active
ReLine	11210130P	FDA UDI	Class II	Active
ReLine	3736515	FDA UDI	Class II	Active
ReLine	13210590	FDA UDI	Class II	Active
ReLine	14529560	FDA UDI	Class II	Active
ReLine	10150360	FDA UDI	Class II	Active
X-Core	1651997	FDA UDI	Class I	Active
ReLine	10200205	FDA UDI	Class II	Active
ReLine	16115050	FDA UDI	Class II	Active
Precept	8837030A	FDA UDI	Class II	Active
CoRoent	5494404	FDA UDI	Class II	Active
Mas Plif	7885035	FDA UDI	Class II	Active
CoRoent	5280302P2	FDA UDI	Class II	Active
PEEK Corpectomy	5971448	FDA UDI	Class II	Active
Helix	7738248	FDA UDI	Class II	Active
Precept	8886550	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

AJW Technology Consulting GmbH DE

Importers

Not available yet.

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.

Date	Recall No.	Class	Status	Reason
Nov 10, 2022	Z-0738-2023	—	open, classified	Potential that insert will be unable to disengage from the vertebral body replacement device/implant
Jul 19, 2022	Z-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, 2022	Z-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, 2020	Z-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, 2020	Z-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, 2009	Z-0369-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0361-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0351-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0370-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0375-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0348-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0354-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0377-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0355-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0374-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0378-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0352-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0372-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0363-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0350-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0364-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0367-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0359-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0366-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0373-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0362-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0349-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0360-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0353-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0365-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0376-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0371-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0357-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0358-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0368-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.
Jan 5, 2009	Z-0356-2013	—	terminated	The tulip portion of the screw assembly can disengage from the shank after implantation.