Alta ACDF System
510(k) K152622
Alta ACDF System is a Class II device made by Biomet Spine LLC, cleared under FDA 510(k) K152622 on 8 Jul 2016, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK152622 | Date8 Jul 2016 | StatusActive |
Official records
- FDA 510(k) database K152622
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OVE
- FDA applicant
- Biomet Spine
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical).
- Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System by Life Spine, Inc.
- Stable-C Interbody System by NEXUS SPINE, LLC.
- Unispace SA Cervical Cage by Edisoninno Co., Ltd.
- SAGICO Spinal System by Sagico VA USA, LLC
- ACDF Stand Alone Cervical 03.18.751 by Medacta International SA
- Tesera-K SC System by Kyocera Medical Technologies, Inc.
- HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) by GLOBUS MEDICAL, INC.
- Paramount Anterior Cervical Cage System by Spine Wave, Inc.
- CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE by Theken Spine, LLC
- ACDF Stand Alone Cervical 03.18.419 by Medacta International SA