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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 4 of 500

Device	Model / Reference	Registries	Class	Status
CoRoent	5470304	FDA UDI	Class II	Active
X-Core	6591027	FDA UDI	Class II	Active
ReLine	D1608064	FDA UDI	Class I	Active
Halo	7876532	FDA UDI	Class II	Active
Armada	8456535	FDA UDI	Class II	Active
ReLine	10100506	FDA UDI	Class II	Active
Acp	18006135	FDA UDI	Class II	Active
ReLine	16514545P	FDA UDI	Class II	Active
Simplify	TMP	FDA UDI	Class III	Active
ReLine	24021012	FDA UDI	Class II	Active
ReLine	3923524	FDA UDI	Class II	Active
ReLine	12260130	FDA UDI	Class II	Active
ReLine	11019095	FDA UDI	Class II	Active
Armada	1596170	FDA UDI	Class I	Active
ReLine	3837544	FDA UDI	Class II	Active
Acp	18002355	FDA UDI	Class II	Active
Acp	18002484	FDA UDI	Class II	Active
ReLine	3735525	FDA UDI	Class II	Active
ReLine	8511002	FDA UDI	Class I	Active
CoRoent	5164302	FDA UDI	Class II	Active
ReLine	13082590	FDA UDI	Class II	Active
ReLine	13119565	FDA UDI	Class II	Active
Instruments	6900305	FDA UDI	Class I	Active
CoRoent	6850117	FDA UDI	Class II	Active
ReLine	17150001	FDA UDI	Class II	Active
CoRoent	6810815	FDA UDI	Class II	Active
ReLine	14155085	FDA UDI	Class II	Active
ReLine	11039540	FDA UDI	Class II	Active
ReLine	24026570	FDA UDI	Class II	Active
ReLine	3945700	FDA UDI	Class II	Active
ReLine	3900302	FDA UDI	Class II	Active
CoRoent	5294364P2	FDA UDI	Class II	Active
ReLine	15355160P	FDA UDI	Class II	Active
ReLine	RSSEXTRACOREIN	FDA UDI	Class II	Active
ReLine	13054575A	FDA UDI	Class II	Active
ReLine	16017075	FDA UDI	Class II	Active
ReLine	13044030	FDA UDI	Class II	Active
ReLine	13019535	FDA UDI	Class II	Active
ReLine	14360195	FDA UDI	Class II	Active
ReLine	11025595	FDA UDI	Class II	Active
ReLine	3900327	FDA UDI	Class II	Active
CoRoent	5152288	FDA UDI	Class II	Active
ReLine	16029030	FDA UDI	Class II	Active
ReLine	13065580	FDA UDI	Class II	Active
ReLine	15055230	FDA UDI	Class II	Active
ReLine	14155065	FDA UDI	Class II	Active
ReLine	13021590	FDA UDI	Class II	Active
ReLine	15255370	FDA UDI	Class II	Active
ReLine	13067055	FDA UDI	Class II	Active
XLIF Decade Plate	1631037	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

AJW Technology Consulting GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.