Amendia Stand-Alone Cervical System
FDA 510(k) clearance K152972 · decided 2016-01-14
Clearance details
- K-number
- K152972
- Device name
- Amendia Stand-Alone Cervical System
- Applicant
- Amendia, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-10-08
- Decision date
- 2016-01-14
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- OVE
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Marietta, GA, US
- Third-party review
- No
- Expedited review
- No
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| SAGI Cervical Cage System (K253213) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-20 |
| Uni-C Cervical Cage System (K252774) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-04-15 |
| E3D™-C Interbody System (K260038) | Evolution Spine | 2026-02-04 |
| HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) (K253876) | Globus Medical, Inc. | 2025-12-22 |
| Cervical Spine Truss System - Stand Alone (CSTS-SA) (K253200) | 4Web Medical, Inc. | 2025-12-11 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical inter recall (Z-0966-2017) | Amendia, Inc | 2017-01-09 |