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

Globus Medical, Inc.: FDA-registered device maker in Memphis, TN, United States, 262 510(k) clearances and 3 PMA approvals

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

Globus Medical, Inc. is registered with the FDA (registration 3030412764) in Memphis, TN, United States. It lists 77 device types. The FDA files 262 510(k) clearances and 3 PMA approvals under its listings, the newest dated August 4, 2026. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Globus Medical, Inc.

FDA registration number: 3030412764
Address: 4670 E. Shelby DR, Memphis, TN, United States, 38118
Owner or operator: GLOBUS MEDICAL, INC. (9056090)
Roles: Manufacturer
First device listed: June 21, 1995
Registered through: 2026
Brand names listed: 20% Buffered Formalin, ACP, ACTIFY 3D, ACTIFY Uni, ALIF Buttress Plate, ANTHEM, APX, AUTOBAHN and more

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Spinal Interlaminal	KWP	2	Manufacturer	accessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral Body	KWQ	2	Manufacturer	accessdata.fda.gov
Bit, Drill	HTW	1	Manufacturer	accessdata.fda.gov
Bone Cement, Posterior Screw Augmentation	PML	2	Manufacturer	accessdata.fda.gov
Bone Fixation Cerclage, Sublaminar	OWI	2	Manufacturer	accessdata.fda.gov
Bur, Surgical, General & Plastic Surgery	GFF	1	Manufacturer	accessdata.fda.gov
Cement, Bone, Vertebroplasty	NDN	2	Manufacturer	accessdata.fda.gov
Cerclage, Fixation	JDQ	2	Manufacturer	accessdata.fda.gov
Cuff, Tracheal Tube, Inflatable	BSK	2	Manufacturer	accessdata.fda.gov
Device, Fixation, Proximal Femoral, Implant	JDO	2	Manufacturer	accessdata.fda.gov
Electromyograph, Diagnostic	IKN	2	Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Manufacturer	accessdata.fda.gov
Filler, Bone Void, Calcium Compound	MQV	2	Manufacturer	accessdata.fda.gov
Formalin, Neutral Buffered	IFP	1	Manufacturer	accessdata.fda.gov
Growing Rod System	PGM	2	Manufacturer	accessdata.fda.gov
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented	OQG	2	Manufacturer	accessdata.fda.gov
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented	OQI	2	Manufacturer	accessdata.fda.gov
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented	OQH	2	Manufacturer	accessdata.fda.gov
Impactor	HWA	1	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Manufacturer	accessdata.fda.gov
Interventional Fluoroscopic X-Ray System	OWB	2	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Thoracic	PHM	2	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Cervical	OVE	2	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, Lumbar	OVD	2	Manufacturer	accessdata.fda.gov
Light, Surgical, Fiberoptic	FST	2	Manufacturer	accessdata.fda.gov
Manual Instruments Designed For Use With Total Disc Replacement Devices	QLQ	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical, Polymeric	FTL	2	Manufacturer	accessdata.fda.gov
Mixer, Cement, For Clinical Use	JDZ	1	Manufacturer	accessdata.fda.gov
Motor, Surgical Instrument, Ac-Powered	GEY	1	Manufacturer	accessdata.fda.gov
Nail, Fixation, Bone	JDS	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	Manufacturer	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Manufacturer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Manufacturer	accessdata.fda.gov
Orthosis, Spine, Plate, Laminoplasty, Metal	NQW	2	Manufacturer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Manufacturer	accessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	OSH	2	Manufacturer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Manufacturer	accessdata.fda.gov
Posterior Cervical Screw System	NKG	2	Manufacturer	accessdata.fda.gov
Posterior Metal/Polymer Spinal System, Fusion	NQP	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	MAY	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Femoral Component, Cemented, Metal	JDG	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal	KWL	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	KWY	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	LZO	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	JDI	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	LPH	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	LWJ	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	MBL	2	Manufacturer	accessdata.fda.gov
Prosthesis, Intervertebral Disc	MJO	3	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	HSX	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	MBH	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	OIY	2	Manufacturer	accessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	2	Manufacturer	accessdata.fda.gov
Retractor	GAD	1	Manufacturer	accessdata.fda.gov
Rod, Fixation, Intramedullary And Accessories	HSB	2	Manufacturer	accessdata.fda.gov
Sacroiliac Joint Fixation	OUR	2	Manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Manufacturer	accessdata.fda.gov
Spinal Vertebral Body Replacement Device	MQP	2	Manufacturer	accessdata.fda.gov
Spinal Vertebral Body Replacement Device - Cervical	PLR	2	Manufacturer	accessdata.fda.gov
Spinous Process Plate	PEK	2	Manufacturer	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
Syringe, Piston	FMF	2	Manufacturer	accessdata.fda.gov
System, Facet Screw Spinal Device	MRW	U	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Manufacturer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Manufacturer	accessdata.fda.gov
Tube, Tracheal (W/Wo Connector)	BTR	2	Manufacturer	accessdata.fda.gov
Vertebral Body Tethering System	QHP	N	Manufacturer	accessdata.fda.gov
Washer, Bolt Nut	HTN	2	Manufacturer	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 262.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 4, 2026	K254043	TRIVANCE Hip Stem	LPH	Substantially Equivalent	Globus Medical, Inc.	accessdata.fda.gov
July 31, 2026	K262251	ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)	JWH	Substantially Equivalent	Globus Medical, Inc.	accessdata.fda.gov
June 18, 2026	K261651	Precice Max System and Precice Ankle Salvage System	HSB	Substantially Equivalent	NuVasive Specialized Orthopedics	accessdata.fda.gov
April 24, 2026	K261043	AUTOBAHN Nailing System	HSB	Substantially Equivalent	Globus Medical, Inc.	accessdata.fda.gov
February 26, 2026	K252166	RIB LINK Fixation System	HRS	Substantially Equivalent	Globus Medical, Inc.	accessdata.fda.gov
August 18, 2025	K251161	ANTHEM® Fracture System	HRS	Substantially Equivalent	Globus Medical, Inc.	accessdata.fda.gov
June 6, 2025	K243456	ONVOY Acetabular System	LPH	Substantially Equivalent	Globus Medical, Inc.	accessdata.fda.gov
December 6, 2024	K241260	ACTIFY Unicondylar Knee System	HSX	Substantially Equivalent	Globus Medical, Inc.	accessdata.fda.gov
June 20, 2024	K240669	ACTIFY 3D Total Knee System, ACTIFY Total Knee System	JWH	Substantially Equivalent	Globus Medical, Inc.	accessdata.fda.gov
June 3, 2024	K240947	TENSOR® Suture Button System	HTN	Substantially Equivalent	Globus Medical, Inc.	accessdata.fda.gov
April 29, 2024	K240568	DuraPro Oscillating System	OLO	Substantially Equivalent	Globus Medical, Inc.	accessdata.fda.gov
February 9, 2024	K233638	VERZA High Speed Drills	OLO	Substantially Equivalent	Globus Medical, Inc.	accessdata.fda.gov
August 4, 2023	K231333	STRETTO Cable System	JDQ	Substantially Equivalent	Globus Medical, 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 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
September 9, 2022	K220659	AUTOBAHN(R) EVO Femoral Nails	HSB	Substantially Equivalent	Globus Medical, Inc.	accessdata.fda.gov
August 11, 2022	K221737	InstaFill Graft Delivery System, SIGNIFY Bioactive	FMF	Substantially Equivalent	Globus Medical, Inc.	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
July 31, 2020	K201087	CORBEL Spacers	OVD	Substantially Equivalent	Globus Medical, Inc.	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
January 14, 2020	K192115	SABLE Expandable Spacer	MAX	Substantially Equivalent	Globus Medical, Inc.	accessdata.fda.gov
November 13, 2019	K192582	NuVasive CoRoent Small Interlock System	OVE	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 18, 2019	K191391	HEDRON Lumbar Spacers	MAX	Substantially Equivalent	Globus Medical, Inc.	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
April 8, 2019	K182375	CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS®	NKB	Substantially Equivalent	Globus Medical, Inc.	accessdata.fda.gov
March 21, 2019	K190418	NuVasive® VersaTie® System	OWI	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
March 8, 2019	K190276	Provident II Hip Stem	LPH	Substantially Equivalent	Stelkast, Inc.	accessdata.fda.gov
February 13, 2019	K182974	NuVasive Reline System	NKB	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
February 6, 2019	K183119	SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments	OUR	Substantially Equivalent	Globus Medical, Inc.	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
January 19, 2018	K173875	GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert	JWH	Substantially Equivalent	Stelkast, Inc.	accessdata.fda.gov
December 29, 2017	K171108	AUTOBAHN Nailing System	HSB	Substantially Equivalent	Globus Medical, Inc.	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 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 9, 2017	K162315	FORTIFY Corpectomy Spacers	MQP	Substantially Equivalent	Globus Medical, Inc.	accessdata.fda.gov
November 6, 2017	K172979	NuVasive® Growth Rod Conversion Set	PGM	Substantially Equivalent	Nu Vasive, Incorporated	accessdata.fda.gov
October 26, 2017	K172417	SILC® Fixation System	OWI	Substantially Equivalent	Globus Medical, Inc.	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
April 7, 2017	K163361	ANTHEM Fracture System	HRS	Substantially Equivalent	Globus Medical, Inc.	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
January 23, 2017	K162618	CONCORD Plus Radiopaque Bone Cement	NDN	Substantially Equivalent	Globus Medical, Inc.	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
September 21, 2016	K161591	QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments	NKG	Substantially Equivalent	Globus Medical, Inc.	accessdata.fda.gov
August 29, 2016	K160597	INDEPENDENCE MIS Spacers	OVD	Substantially Equivalent	Globus Medical, Inc.	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

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
September 28, 2012	P100003	SECURE-C ARTIFICIAL CERVICAL DISC	MJO	8	June 12, 2023	accessdata.fda.gov

Compare with other makers

Updated August 4, 2026. 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.