AVS ANCHOR-C CERVICAL CAGE SYSTEM
FDA 510(k) clearance K102606 · decided 2011-04-22
Clearance details
- K-number
- K102606
- Device name
- AVS ANCHOR-C CERVICAL CAGE SYSTEM
- Applicant
- Stryker Spine
- Decision
- Substantially Equivalent
- Date received
- 2010-09-10
- Decision date
- 2011-04-22
- Days to decision
- 224 days
- Clearance type
- Traditional
- Product code
- OVE
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Allendale, NJ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Stryker Spine
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ZSAlign Cervical Interbody System (K261451) | ZSFab, Inc. | 2026-07-31 |
| E3D™-C Interbody System (K262094) | Evolution Spine | 2026-07-22 |
| DeltaNEC Interbody System (K261279) | Nexus Spine | 2026-06-22 |
| CONDUIT™ ZERO-P™ VA Secured Spacer System (K252982) | Avalign Technologies, Inc. | 2026-06-18 |
| NeckTune™ 3D SA Cervical Cage (K260036) | Medyssey Co, Ltd. | 2026-06-15 |
| SABER-C System (K260660) | Elevation Spine | 2026-04-27 |
| 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 |
| Endeavor™ Stand-Alone Cervical IBF System (K250076) | Innovasis | 2025-09-25 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated recall (Z-3210-2024) | Stryker Spine | 2024-09-23 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| RAY TFC AND RAY TFC UNITE (P950019/S014) | Stryker Spine | 2004-03-25 |
| RAY TFC UNITE (P950019/S016) | Stryker Spine | 2003-10-10 |
| RAY THREADED FUSION CAGE (TFC) (P950019/S015) | Stryker Spine | 2003-09-04 |
| RAY TFC UNITE PRODUCT LINE (P950019/S013) | Stryker Spine | 2003-07-15 |
| RAY TFC DEVICE/RAY TFC UNITE DEVICE (P950019/S012) | Stryker Spine | 2002-04-02 |
| RAY THREADED FUSION CAGE(TFC-TM) DEVICE WITH INSTRUMENTATION (P950019/S011) | Stryker Spine | 2000-03-30 |
| RAY TFC DEVICE AND RAY TFC UNITE DEVICE (P950019/S009) | Stryker Spine | 2000-03-02 |
| RAY THREADED FUSION CAGE(TFC) (P950019/S010) | Stryker Spine | 1999-12-01 |