OVE · Intervertebral Fusion Device With Integrated Fixation, Cervical

Device class

Class II

Regulation 888.3080

Total clearances

2020-01-08 → 2026-07-31

Last 12 months

Unique sponsors

Definition

What is Intervertebral Fusion Device With Integrated Fixation, Cervical

Intended to stabilize cervical 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
SeaSpine Orthopedics Corporation	5	0	2023-11-28
4Web Medical	4	1	2025-12-11
Genesys Spine	3	0	2025-02-07
Nexus Spine, LLC	3	1	2026-06-22
Evolution Spine	3	2	2026-07-22
Elevation Spine	2	1	2026-04-27
Medacta International S.A.	2	0	2020-11-06
GS Medical Co., Ltd.	2	0	2023-07-20
Spinevision, S.A.S.	2	0	2022-11-14
Corelink, LLC	2	0	2022-02-04
Kyocera Medical Technologies, Inc.	2	0	2025-04-10
Camber Spine Technologies	2	0	2023-03-22
ZheJiang Decans Medical Devices Co., Ltd.	2	2	2026-04-20
Choice Spine, LLC	2	0	2023-09-14
Sagico VA USA, LLC	2	0	2023-08-04
Astura Medical, LLC	1	0	2020-10-26
Jeil Medical Corporation	1	0	2025-06-27
Spineup, Inc.	1	0	2022-01-10
Eminent Spine, LLC	1	0	2021-11-05
Spinal Analytics & Geometrical Implant Co, LLC	1	0	2023-11-21
Nexxt Spine, LLC	1	0	2020-03-23
Signus Medizintechnik GmbH	1	0	2025-02-11
Innosys Co., Ltd.	1	0	2024-04-19
Acuity Surgical Devices, LLC	1	0	2025-07-30
Innovasis	1	1	2025-09-25

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
22554	CPT	—	High	Arthrodesis, anterior approach, including rib excision, cervical; single interspace
22585	CPT	—	High	Arthrodesis, anterior approach, including rib excision, cervical; each additional interspace

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-31	K261451	ZSFab, Inc.	ZSAlign Cervical Interbody System
2026-07-22	K262094	Evolution Spine	E3D-C Interbody System
2026-06-22	K261279	Nexus Spine	DeltaNEC Interbody System
2026-06-18	K252982	Avalign Technologies, Inc.	CONDUIT ZERO-P VA Secured Spacer System
2026-06-15	K260036	Medyssey Co, Ltd.	NeckTune 3D SA Cervical Cage
2026-04-27	K260660	Elevation Spine	SABER-C System
2026-04-20	K253213	ZheJiang Decans Medical Devices Co., Ltd.	SAGI Cervical Cage System
2026-04-15	K252774	ZheJiang Decans Medical Devices Co., Ltd.	Uni-C Cervical Cage System
2026-02-04	K260038	Evolution Spine	E3D-C Interbody System
2025-12-22	K253876	Globus Medical, Inc.	HEDRON Cervical Spacers (HEDRON C-MIS Spacer)
2025-12-11	K253200	4Web Medical, Inc.	Cervical Spine Truss System - Stand Alone (CSTS-SA)
2025-09-25	K250076	Innovasis	Endeavor Stand-Alone Cervical IBF System
2025-08-08	K250540	Elevation Spine	SABER-C System
2025-07-30	K251735	Acuity Surgical Devices, LLC	Stabilis SA Cervical Stand-Alone System (Various PNs)
2025-06-27	K251431	Jeil Medical Corporation	FIX-C PEEK ACIF SA System
2025-04-25	K251117	4Web Medical	Cervical Spine Truss System (CSTS)
2025-04-10	K242928	Kyocera Medical Technologies, Inc.	Tesera-k SC System
2025-02-11	K243188	Signus Medizintechnik GmbH	CYLOX® ST
2025-02-07	K242483	Genesys Spine	Genesys Spine AIS-C II Cervical Interbody Fusion System
2024-11-20	K242517	Pro Surgical, Inc.	ProAM ACDF System
2024-08-12	K241846	Evolution Spine	E3D-C Interbody System
2024-07-17	K241467	Nexus Spine, LLC	Stable-C Interbody System
2024-05-10	K240699	Spineart SA	SCARLET® AC-Ti
2024-04-19	K234119	Innosys Co., Ltd.	UniSpace® Stand-Alone C Cage
2024-03-22	K240715	Clariance	Idys® C ZP 3DTi