KWQ · Appliance, Fixation, Spinal Intervertebral Body

Device class

Class II

Regulation 888.3060

Total clearances

110

2020-02-05 → 2026-07-16

Last 12 months

Unique sponsors

Classification details

Medical specialty

Orthopedic

Review panel

Regulation number

888.3060

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
Alphatec Spine, Inc.	5	1	2025-08-28
L&K BIOMED Co., Ltd.	4	2	2026-05-06
SeaSpine Orthopedics Corporation	4	0	2021-09-01
Nu Vasive, Incorporated	4	0	2021-11-03
Vy Spine, LLC	3	1	2026-03-27
Pioneer Surgical Technology, Inc.	3	0	2025-07-11
MiRus, LLC	2	0	2024-05-17
4Web, Inc.	2	1	2026-02-12
Meditech Spine, LLC	2	0	2021-03-18
Kyocera Medical Technologies Inc. (KMTI)	2	0	2025-04-10
Huvexel Co. , Ltd.	2	0	2022-03-25
Nexxt Spine, LLC	2	0	2024-03-22
Life Spine, Inc.	2	0	2024-12-11
Globus Medical, Inc.	2	0	2024-01-25
Clariance	2	0	2025-01-14
Precision Spine, Inc.	2	0	2022-03-16
Oak Tree Engineering, LLC	2	0	2022-12-07
Omnia Medical, LLC	2	0	2023-04-12
Evolution Spine	2	0	2022-03-18
Gbs Commonwealth Co., Ltd.	2	0	2021-08-12
Icotec AG	2	0	2024-05-17
Spinal Elements, Inc.	2	0	2023-08-02
Carlsmed, Inc.	2	2	2026-04-22
Ctl Medical Corporation	2	0	2024-01-26
Osteonic Co., Ltd.	1	1	2026-02-26

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
22856	CPT	—	High	Standard CPT for interbody fusion/device insertion in spinal fixation
22857	CPT	—	Medium	CPT for additional intervertebral disc space fusion

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-16	K261309	Bethesda Medical Devices, LLC	Palisades Buttress Plate System
2026-05-14	K252776	ZheJiang Decans Medical Devices Co., Ltd.	ARIES Anterior Cervical Plate Systems
2026-05-06	K261112	L&K BIOMED Co., Ltd.	CastleLoc-P Anterior Cervical Plate System
2026-04-22	K260570	Carlsmed, Inc.	corra cervical plating system
2026-03-27	K260697	Vy Spine, LLC	VyPlate Anterior Cervical Plate System
2026-03-04	K260015	SpineCraft	ANTERIS Thoracolumbar Plate System
2026-03-03	K251940	L&K BIOMED Co., Ltd.	PathLoc Lumbar Plate System
2026-02-26	K254182	Osteonic Co., Ltd.	Aster
2026-02-12	K253201	4Web, Inc.	Lumbar Spine Truss System - Plating Solution (LSTS-PS)
2025-12-22	K252611	Carlsmed, Inc.	aprevo® cervical plating system
2025-08-28	K251965	Alphatec Spine, Inc.	Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)
2025-07-11	K251436	Pioneer Surgical Technology, Inc.	Resolve Anterior Cervical Plate System
2025-05-23	K250446	Spineup, Inc.	Frida Anterior Cervical Plate System
2025-05-20	K250602	Expanding Innovations, Inc.	X-PAC® N-GAGE Lumbar Plate System
2025-04-10	K250486	Kyocera Medical Technologies Inc. (KMTI)	Skyway Anterior Cervical Plate System
2025-01-14	K243904	Clariance	Elegance® Anterior Cervical plate
2024-12-11	K243369	Life Spine, Inc.	Cervical Plating System
2024-11-07	K242361	Stryker Spine	OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI
2024-11-05	K243015	Kyocera Medical Technologies, Inc.	Skyway Anterior Cervical Plate System
2024-07-24	K231251	Jeil Medical Corporation	FlexWing Anterior Cervical Plate System
2024-05-24	K240592	Spinal Simplicity, LLC	Wolff's Law Anterior Cervical Plate System
2024-05-17	K241175	MiRus, LLC	MiRus MoRe Lumbar Plating System
2024-05-17	K240935	Effortmed, LLC	ARENAL Anterior Cervical Plate System
2024-05-17	K233215	Icotec AG	icotec Anterior Cervical Plate System
2024-04-17	K240484	Mikron Makina Sanayi VE Ticaret Ltd. Sti.	MSFX Mikron Cervical Anterior Plate System