Cervical Cage
510(k) K122444
Cervical Cage is a Class II device made by Eisertech, LLC, cleared under FDA 510(k) K122444 on 30 Aug 2012, 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 | NumberK122444 | Date30 Aug 2012 | StatusActive |
Official records
- FDA 510(k) database K122444
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ODP
- 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 ODP (Intervertebral Fusion Device With Bone Graft, Cervical).
- VU C*POD INTERVERTEBRAL BODY FUSION DEVICE by Theken Spine, LLC
- Keos Anterior Cervical Interbody Fusion Device System by KEOS
- Mecta-C Cervical Ti-Peek Cages 03.28.712 by Medacta International SA
- Reliance Cervical IBF System by Reliance Medical Systems, LLC
- CONSTRUX Mini Ti Spacer System by Orthofix, Inc.
- PROVIDENCE CERVICAL CAGE by Providence Medical Technology
- Mecta-C Ti mark 03.28.215 by Medacta International SA
- SureMAX Family of Cervical Spacers by Additive Implants, Inc.
- uCerv Flux™-C 3D Porous Titanium Cervical Interbody by ULRICH MEDICAL USA, INC.
- TRABECULAR METAL (TM) FUSION DEVICE by ZIMMER SPINE, INC.