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Nuvasive, Inc.

United States·US-MF-000007421

Last updated September 17, 2026

What Nuvasive, Inc. makes

Nuvasive, Inc. manufactures spinal fixation devices, including non-bioabsorbable bone screws, metallic and polymeric interbody fusion cages, and internal fixation rods for surgical stabilization. Their portfolio also includes spinal implant trials, non-bioabsorbable spinal plates, reusable surgical retraction systems, and reusable internal fixation procedure kits. Devices like ReLine, CoRoent, BASE, Precept, XLIF, and TLIF are designed for spinal procedures such as fusion and stabilization.

The company’s products are regulated under FDA classifications, including Class I, Class II, and Class III devices, and are listed in the FDA’s Unique Device Identifier (UDI) database. Nuvasive, Inc. is headquartered in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Nuvasive, Inc. primarily manufacture?

Nuvasive, Inc. specializes in spinal fixation devices, including non-bioabsorbable bone screws, metallic and polymeric interbody fusion cages, internal spinal fixation rods, and non-bioabsorbable spinal plates. Their portfolio also covers reusable surgical retraction systems, reusable internal fixation procedure kits, and spinal implant trials. These devices are designed for procedures like spinal fusion and stabilization, such as the ReLine, CoRoent, BASE, Precept, XLIF, and TLIF systems.

Where is Nuvasive, Inc. based, and what does that mean for its regulatory oversight?

Nuvasive, Inc. is headquartered in the United States, which means its devices are subject to FDA regulation. The FDA classifies their products as Class I, Class II, or Class III based on risk levels, with higher-risk devices requiring stricter premarket authorization processes. The company’s devices are also listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance tracking.

Which regulatory registries or databases list Nuvasive, Inc.’s devices?

Nuvasive, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and compliance with regulatory requirements. The UDI system assigns a unique code to each device, aiding in post-market surveillance and recall management.

How are Nuvasive, Inc.’s devices classified under FDA regulations?

Nuvasive, Inc.’s devices fall into three FDA classification tiers: Class I (low-risk, generally exempt from premarket review), Class II (moderate-risk, requiring special controls beyond general controls), and Class III (high-risk, requiring premarket approval). Classification depends on factors like the device’s purpose, potential harm if it fails, and the duration of use. For example, spinal fixation rods and interbody cages are often Class II or III due to their critical role in spinal stability and long-term performance.

AI-generated from registry data and not verified by a human reviewer.

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 35 of 500

Device	Model / Reference	Registries	Class	Status
CoRoent	5203288	FDA UDI	Class II	Active
CoRoent	5290324	FDA UDI	Class II	Active
Mlx	1608402	FDA UDI	Class I	Active
Brigade	8921634	FDA UDI	Class II	Active
ReLine	3803542	FDA UDI	Class II	Active
Armada	8274550	FDA UDI	Class II	Active
CoRoent	5149324P2	FDA UDI	Class II	Active
ReLine	14544070	FDA UDI	Class II	Active
ReLine	11010351	FDA UDI	Class II	Active
CoRoent	5241302P2	FDA UDI	Class II	Active
Base	6959182	FDA UDI	Class II	Active
Acp	8786482	FDA UDI	Class II	Active
CoRoent	5201280P2	FDA UDI	Class II	Active
ReLine	11360125	FDA UDI	Class II	Active
ReLine	12055120	FDA UDI	Class II	Active
X-Core	XCOREMINI	FDA UDI	Class II	Active
Precept	8886560	FDA UDI	Class II	Active
Archon	8883362	FDA UDI	Class II	Active
Archon	8787474	FDA UDI	Class II	Active
Helix	7802213	FDA UDI	Class II	Active
ReLine	14587555	FDA UDI	Class II	Active
ReLine	14619055	FDA UDI	Class II	Active
Monolith	5991248	FDA UDI	Class II	Active
CoRoent	6010850P	FDA UDI	Class II	Active
Acp	8786510	FDA UDI	Class II	Active
ReLine	11000428	FDA UDI	Class I	Active
Acp	8786235	FDA UDI	Class II	Active
CoRoent	5169324P2	FDA UDI	Class II	Active
XLIF Decade Plate	1631658	FDA UDI	Class II	Active
CoRoent	5271304	FDA UDI	Class II	Active
CoRoent	5181320	FDA UDI	Class II	Active
Simplify® Cervical Artificial Disc	F	FDA UDI	Class III	Active
X-Core	6539018	FDA UDI	Class II	Active
CoRoent	6306210	FDA UDI	Class II	Active
ReLine	12160120	FDA UDI	Class II	Active
ReLine	10055145	FDA UDI	Class II	Active
ReLine	11011550	FDA UDI	Class II	Active
ReLine	3735038	FDA UDI	Class II	Active
ReLine	10017590	FDA UDI	Class II	Active
NuVasive	Z300045-01	FDA UDI	Class II	Active
CoRoent	5123285P2	FDA UDI	Class II	Active
ReLine	3803550	FDA UDI	Class II	Active
CoRoent	6725335	FDA UDI	Class II	Active
ReLine	13028085	FDA UDI	Class II	Active
Traverse	7250035	FDA UDI	Class I	Active
Xlif	6943414	FDA UDI	Class I	Active
Simplify	57100355P2	FDA UDI	Class III	Active
X-Core	5962747	FDA UDI	Class II	Active
Precept	8801279	FDA UDI	Class II	Active
ReLine	10018535	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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Importers

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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.

Nuvasive, Inc. has 36 recall records initiated between January 5, 2009, and November 10, 2022. The records include open, classified, and terminated statuses. Reasons cited involve component failures such as actuator end cap separation, incorrect security keys affecting remote monitoring connectivity, incorrect component shipments in neurophysiologic monitoring kits, potential disengagement of surgical inserts, mislabeled barcodes on cervical artificial discs, and screw assembly disengagement post-implantation.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

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.