OVD · Intervertebral Fusion Device With Integrated Fixation, Lumbar

Device class

Class II

Regulation 888.3080

Total clearances

2020-01-08 → 2026-08-03

Last 12 months

Unique sponsors

Definition

What is Intervertebral Fusion Device With Integrated Fixation, Lumbar

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Classification details

Medical specialty

Orthopedic

Review panel

Regulation number

888.3080

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Carlsmed, Inc.	4	0	2025-03-17
Nu Vasive, Incorporated	4	0	2023-06-16
Nexus Spine, LLC	4	0	2025-04-30
Kyocera Medical Technologies, Inc.	4	1	2026-07-15
Evolution Spine	3	0	2024-05-15
Alphatec Spine, Inc.	3	1	2025-09-03
Astura Medical	3	0	2023-01-19
Medacta International S.A.	3	1	2026-05-05
Acuity Surgical Devices, LLC	3	0	2025-04-22
Axis Spine Technologies, Ltd.	2	0	2021-09-29
Omnia Medical, LLC	2	0	2024-04-24
MiRus, LLC	2	0	2023-09-11
Innovasis	2	0	2025-03-24
Globus Medical, Inc.	2	1	2026-04-29
Novapproach Spine, LLC	2	0	2025-06-12
Osseus Fusion Systems	2	0	2023-02-10
Foundation Surgical Group, Inc.	2	1	2026-07-31
Degen Medical	2	1	2025-12-08
Pro Surgical, Inc.	2	0	2025-06-24
Camber Spine Technologies	1	0	2023-03-30
Spineart	1	0	2020-01-22
Nexxt Spine, LLC	1	0	2020-12-15
Stryker Corporation	1	0	2020-08-10
Spinal Elements, Inc.	1	1	2026-02-25
4Web, Inc.	1	0	2020-05-29

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
22630	CPT	—	High	Arthrodesis, posterior approach, including laminectomy and/or foraminotomy, lumbar, single level
22632	CPT	—	High	Arthrodesis, posterior approach, lumbar; each additional level
C9143	HCPCS	Cocaine hydrochloride nasal solution (numbrino), 1 mg ✓ CMS-verified description	Medium	Injection, collagen meniscus implant procedure includes all arthrocentesis to inject implant material

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-03	K261408	Elevation Spine	SABER-XA System
2026-07-31	K261809	Foundation Surgical Group	Interwedge® Standalone Lateral
2026-07-15	K261353	Kyocera Medical Technologies, Inc.	Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System
2026-06-10	K260810	Tyber Medical, LLC	Anteralign LS coverplate
2026-05-05	K254202	Medacta International S.A.	MectaLIF 3D Metal Anterior
2026-04-29	K253401	Globus Medical, Inc.	SCRIPT Implant System
2026-02-25	K253559	Spinal Elements, Inc.	Ventana A Anterior Lumbar Interbody System
2025-12-08	K251829	Degen Medical	DeGen Medical Patient Specific Implant (PSI) System
2025-09-03	K251575	Alphatec Spine	IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System
2025-07-10	K250072	Avalign Technologies, Inc.	CONDUIT SYNFIX Evolution Secured Spacer System
2025-06-24	K251644	Pro Surgical, Inc.	ProAM ALIF System
2025-06-18	K250845	Curiteva, Inc.	Curiteva Porous PEEK Standalone ALIF System
2025-06-12	K251459	Novapproach Spine, LLC	OneLIF Interbody Fusion System
2025-04-30	K243934	Nexus Spine, LLC	Stable-L Lumbar Interbody System
2025-04-22	K243386	Acuity Surgical Devices, LLC	Ventris Intervertebral Body Fusion Device
2025-03-24	K250603	Innovasis	AxTiHA® Stand-Alone ALIF System
2025-03-17	K243802	Carlsmed, Inc.	aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation
2024-12-13	K243635	Carlsmed, Inc.	aprevo® anterior lumbar interbody fusion device with interfixation
2024-11-26	K243191	Atlas Spine, Inc.	Atlas Spine Lateral Expandable Interbody System
2024-10-29	K241077	Degen Medical	DeGen Medical Patient Specific Implant (PSI) System
2024-10-28	K241992	Medtronic Sofamor Danek USA, Inc.	Catalyft LS Expandable Interbody System
2024-10-09	K241477	Carlsmed, Inc.	aprevo® anterior lumbar interbody fusion device with interfixation
2024-10-02	K241487	Foundation Surgical Group, Inc.	Interwedge® Standalone Lateral
2024-07-18	K241321	Spineart SA	Juliet® Ti LL Lumbar Interbody Device
2024-05-15	K240368	Evolution Spine	E3D-A Interbody System