MODIFICATION TO:RADIUS SPINAL SYSTEM
FDA 510(k) clearance K101144 · decided 2010-07-08
Clearance details
- K-number
- K101144
- Device name
- MODIFICATION TO:RADIUS SPINAL SYSTEM
- Applicant
- Stryker Spine
- Decision
- Substantially Equivalent
- Date received
- 2010-04-23
- Decision date
- 2010-07-08
- Days to decision
- 76 days
- Clearance type
- Special
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Allendale, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
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 |