Data / Medical devices / United States / Nuvasive, Inc.

Nuvasive, Inc.: FDA-registered device maker in San Diego, CA, United States, 205 510(k) clearances and 2 PMA approvals

Name: Nuvasive, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Nuvasive, Inc. is registered with the FDA (registration 2031966) in San Diego, CA, United States. It lists 60 device types. The FDA files 205 510(k) clearances and 2 PMA approvals under its listings, the newest dated August 2, 2024. 6 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Nuvasive, Inc.

FDA registration number: 2031966
FEI number: 3002980729
Address: 7475 Lusk Blvd, San Diego, CA, United States, 92121
Owner or operator: NUVASIVE, INC. (9036345)
Roles: Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
First device listed: October 17, 2006
Registered through: 2026
Brand names listed: ARCHON-R ACP, AffiX Next Gen Spinous Process Plate System, Affix II Spinous Process Plate System, Affix Spinous Process Plate System, Archon-R ACP System, Armada Spinal Fixation system, AttraX Granules, AttraX Putty and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Arthroscopic	NBH	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Apparatus, Traction, Non-Powered	HST	1	Manufacturer	accessdata.fda.gov
Appliance, Fixation, Spinal Interlaminal	KWP	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Awl	HWJ	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Bit, Drill	HTW	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Bone Cement, Posterior Screw Augmentation	PML	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Bone Fixation Cerclage, Sublaminar	OWI	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Cable, Electrode	IKD	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Cuff, Tracheal Tube, Inflatable	BSK	2	Manufacturer	accessdata.fda.gov
Driver, Prosthesis	HWR	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Electromyograph, Diagnostic	IKN	2	Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Repackager or relabeler	accessdata.fda.gov
Extractor	HWB	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Filler, Bone Void, Calcium Compound	MQV	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	MBP	2	Repackager or relabeler	accessdata.fda.gov
Gauge, Depth	HTJ	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Growing Rod System	PGM	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Impactor	HWA	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Instrument, Compression	HWN	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Interventional Fluoroscopic X-Ray System	OWB	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Thoracic	PHM	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Cervical	OVE	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Lumbar	OVD	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Light, Surgical, Fiberoptic	FST	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Mallet	HXL	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Manual Instruments Designed For Use With Total Disc Replacement Devices	QLQ	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Mesh, Surgical, Polymeric	FTL	2	Manufacturer	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Manufacturer	accessdata.fda.gov
Neurosurgical Nerve Locator	PDQ	2	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Orthosis, Spine, Plate, Laminoplasty, Metal	NQW	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	OSH	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Posterior Cervical Screw System	NKG	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Prosthesis, Intervertebral Disc	MJO	3	Manufacturer	accessdata.fda.gov
Retractor	GAD	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Rod, Fixation, Intramedullary And Accessories	HSB	2	Manufacturer for export	accessdata.fda.gov
Screwdriver	HXX	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Spinal Vertebral Body Replacement Device	MQP	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Spinal Vertebral Body Replacement Device - Cervical	PLR	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Spinous Process Plate	PEK	2	Manufacturer	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Stimulator, Electrical, Evoked Response	GWF	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve	ETN	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Ac-Powered	BXM	2	Manufacturer	accessdata.fda.gov
Stretcher, Wheeled, Powered	INK	2	Manufacturer	accessdata.fda.gov
System, Facet Screw Spinal Device	MRW	U	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
System, X-Ray, Film Marking, Radiographic	JAC	1	Manufacturer	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Template	HWT	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Tube, Tracheal (W/Wo Connector)	BTR	2	Manufacturer	accessdata.fda.gov
Wrench	HXC	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 205.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 2, 2024	K233706	Bendini Cloud Application	OLO	Substantially Equivalent	Nuvasive	accessdata.fda.gov
March 20, 2024	K240507	NuVasive AttraX Scaffold	MQV	Substantially Equivalent	Nuvasive, Inc.	accessdata.fda.gov
July 11, 2023	K231735	NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System	ODP	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
June 16, 2023	K230894	NuVasive Modulus ALIF System	OVD	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
May 5, 2023	K230989	Rod Registration Frame	OLO	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
January 12, 2023	K223731	NuVasive Modulus-C Interbody System	ODP	Substantially Equivalent	Nuvasive, Inc.	accessdata.fda.gov
January 11, 2023	K223181	NuVasive Reline System	NKB	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
October 21, 2022	K221751	NuVasive Cohere ALIF System Intervertebral Body Fusion Device	OVD	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
September 9, 2022	K221388	NuVasive Reline Cervical System	NKG	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
June 21, 2022	K220478	NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
February 23, 2022	K213654	NuVasive Reline Cervical System	NKG	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
December 23, 2021	K203714	NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
November 3, 2021	K212446	NuVasive Anterior Cervical Plate Systems	KWQ	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
August 20, 2021	K211757	Simplify Disc	QLQ	Substantially Equivalent	Nuvasive, Inc.	accessdata.fda.gov
July 29, 2021	K210574	NuVasive Pulse System	OLO	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
May 24, 2021	K210214	NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
May 12, 2021	K210439	NuVasive MOD-EX XLIF Interbody System	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
March 1, 2021	K210271	NuVasive Modulus ALIF System	OVD	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
January 12, 2021	K203201	NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
December 3, 2020	K203253	NuVasive ACP System	KWQ	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
December 2, 2020	K200719	NuVasive Navigation.S Instruments	OLO	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
October 29, 2020	K201692	NuVasive Modulus XLIF Interbody System	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
October 6, 2020	K200953	NuVasive® Cohere® Thoracolumbar Interbody System	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
September 25, 2020	K201820	NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
May 21, 2020	K200956	NuVasive Thoracolumbar Plates	KWQ	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
May 20, 2020	K201078	NuVasive® ACP System	KWQ	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
March 30, 2020	K193541	NuVasive Cohere Thoracolumbar Interbody System	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
March 25, 2020	K193593	NuVasive 3DP Interfixated ALIF System	OVD	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
February 26, 2020	K193506	NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System	MQP	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
November 13, 2019	K192582	NuVasive CoRoent Small Interlock System	OVE	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
November 3, 2019	K191974	NuVasive AttraX Putty	MQV	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
October 19, 2019	K190636	NuVasive® Reline® 4.5-5.0 System	NKB	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
October 18, 2019	K192760	NuVasive Modulus XLIF Interbody System	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
September 26, 2019	K192435	NuVasive NuvaLine	LLZ	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
September 3, 2019	K191500	NuVasive® ACP System	KWQ	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
August 14, 2019	K191553	NuVaisve® Reline® Cervical System	NKG	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
July 3, 2019	K191169	NuVasive® Camber Laminoplasty System	NQW	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
March 21, 2019	K190418	NuVasive® VersaTie® System	OWI	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
February 13, 2019	K182974	NuVasive Reline System	NKB	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
November 28, 2018	K180498	NuVasive Reline Fenestrated Screws, High V+ Bone Cement	PML	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
November 20, 2018	K180550	NuVasive Monolith Cervical Corpectomy System	PLR	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
October 5, 2018	K181860	NuVasive Cohere Thoracolumbar Interbody System	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
August 24, 2018	K181386	NuVasive Brigade Lateral System	OVD	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
June 29, 2018	K180038	NuVasive Pulse System	OLO	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
May 4, 2018	K173892	NuVasive® XLX Interbody System	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
March 15, 2018	K180198	NuVasive® VuePoint® II OCT System	NKG	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
February 8, 2018	K173025	NuVasive® MLX® Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP Expandable XLIF System	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
December 21, 2017	K172623	NuVasive Navigation Instruments	OLO	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
December 14, 2017	K172676	NuVasive® Modulus-C Interbody System	ODP	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
December 7, 2017	K173117	NuVasive® VersaTie System	OWI	Substantially Equivalent	Nuvasive, Inc.	accessdata.fda.gov
December 6, 2017	K173153	Vertera Spine Coalesce Thoracolumbar Interbody Fusion System	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
November 24, 2017	K172497	NuVasive AttraX Scaffold	MQV	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
November 21, 2017	K173030	Vertera Spine Cohere Cervical Interbody Fusion Device	ODP	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
November 16, 2017	K173314	LessRay System	OWB	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
November 6, 2017	K172979	NuVasive® Growth Rod Conversion Set	PGM	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
October 26, 2017	K172341	NuVasive® Modulus TLIF Interbody System	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
October 11, 2017	K172123	NuVasive® Modulus XLIF Interbody System	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
September 28, 2017	K171894	NuVasive® Precept Spinal System	NKB	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
September 28, 2017	K171633	NuVasive TLX Interbody System	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
August 18, 2017	K170800	NuVasive LessRay with Enhanced Tracking	OWB	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
June 26, 2017	K170962	NuVasive® CoRoent® Thoracolumbar System	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
June 19, 2017	K163506	Coalesce (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System	MAX	Substantially Equivalent	Vertera, Inc.	accessdata.fda.gov
June 8, 2017	K170961	NuVasive CoRoent Small Interlock II System	OVE	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
May 1, 2017	K163707	NuVasive CoRoent Ti-C System	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
May 1, 2017	K162647	NuVasive NuvaLine Mobile App	LLZ	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
April 26, 2017	K170592	NuVasive BASE Interfixated Titanium System	OVD	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
March 30, 2017	K170271	NuVasive(r) Monolith Corpectomy System	MQP	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
March 24, 2017	K163491	NuVasive CoRoent Small Interbody System	ODP	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
March 16, 2017	K163230	NuVasive Modulus XLIF Interbody System	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
March 16, 2017	K162313	NuVasive Next Generation NVM5 System	PDQ	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
March 9, 2017	K170126	NuVasive® Reline® 4.5-5.0 System	NKB	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
October 26, 2016	K162138	NuVasive CoRoent Small Ti-C System	ODP	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
September 28, 2016	K161442	NuVasive® CoRoent® Small Interlock System	OVE	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
September 28, 2016	K161014	NuVasive® Reline® System	NKB	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
August 25, 2016	K161230	NuVasive Lumbar Interbody Implants	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
July 15, 2016	K161265	NuVasive® VersaTie System	OWI	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
July 11, 2016	K153105	MLX - Medial Lateral Expandable Lumbar Interbody System	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
June 28, 2016	K160916	CoRoent® Ti-C System	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
June 9, 2016	K160989	NuVasive® Reline® System	NKB	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
April 20, 2016	K160051	NuVasive® Interfixated Interbody System	OVD	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
April 13, 2016	K153419	NuVasive CoRoent Thoracolumbar System	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
March 24, 2016	K153782	NuVasive® Lumbar Interbody Implants	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
March 17, 2016	K153627	NuVasive® TLX Interbody System	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
January 25, 2016	K151594	Ellipse Supplemental Instrument Trays	KCT	Substantially Equivalent	Ellipse Technologies, Incorporated	accessdata.fda.gov
January 13, 2016	K152942	NuVasiveNVM5 System	PDQ	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
January 7, 2016	K153336	VuePoint OCT System	NKG	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
December 1, 2015	K152943	NuVasive Foundation-LL System	OVD	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
October 21, 2015	K150474	NuVasive VuePoint II OCT System	NKG	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
October 8, 2015	K151584	AttraX Putty	MQV	Substantially Equivalent	Progentix Orthobiology BV	accessdata.fda.gov
September 25, 2015	K151651	NuVasive X-CORE Mini Cervical Expandable VBR System	PLR	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
September 23, 2015	K143685	Hedgehog Cervical Interbody Fusion Device	ODP	Substantially Equivalent	Vertera, Inc.	accessdata.fda.gov
September 10, 2015	K151472	NuVasive CoRoent Lumbar System	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
September 4, 2015	K151538	NuVasive PEEK Corpectomy Railed System	MQP	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
September 3, 2015	K151167	NuVasive PEEK Corpectomy System	MQP	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
August 28, 2015	K143579	NuVasive Sterilization Trays	KCT	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
August 6, 2015	K151374	NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System	MAX	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
June 25, 2015	K151214	ALIF Interfixated System	OVD	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
June 17, 2015	K150994	NuVasive CoRoent Thoracolumbar Implants	PHM	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
June 11, 2015	K150362	NuVasive CoRoent Small Interbody System	ODP	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
April 23, 2015	K143684	NuVasive Reline System	NKB	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
September 18, 2020	P200022	Simplify® Cervical Artificial Disc	MJO	17	June 5, 2025	accessdata.fda.gov
October 26, 2012	P100012	NUVASIVE PCM CERVICAL DISC SYSTEM	MJO	7	April 3, 2019	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
November 10, 2022	91196	Class II	Ongoing	X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.	Potential that insert will be unable to disengage from the vertebral body replacement device/implant	accessdata.fda.gov
July 19, 2022	91294	Class III	Ongoing	NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US	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.	accessdata.fda.gov
June 20, 2022	90500	Class II	Ongoing	Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4; Simplify Disc Size 2, Ht 5/MD-5; Simplify Disc Size 2, Ht 5, 5/MD-5L; Simplify Disc Size 2, Ht 6/MD-6;	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.	accessdata.fda.gov
June 10, 2020	85889	Class II	Terminated	Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery.	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	accessdata.fda.gov
February 13, 2020	85495	Class II	Terminated	NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usage: comprised of a sterile single-use spinal rod that is surgically implanted using appropriate NuVasive Reline, Reline Small Stature, and Arm	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.	accessdata.fda.gov
January 5, 2009	52634	Class II	Terminated	Screw Tulip, 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI	The tulip portion of the screw assembly can disengage from the shank after implantation.	accessdata.fda.gov

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Updated June 5, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.