REFLEX HYBRID ACP SYSTEM
FDA 510(k) clearance K062310 · decided 2006-08-18
Clearance details
- K-number
- K062310
- Device name
- REFLEX HYBRID ACP SYSTEM
- Applicant
- Stryker Spine
- Decision
- Substantially Equivalent
- Date received
- 2006-08-08
- Decision date
- 2006-08-18
- Days to decision
- 10 days
- Clearance type
- Special
- Product code
- KWQ
- Device class
- 2
- Regulation number
- 888.3060
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Allendale, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stryker Reflex Hybrid Screw Extractor; Not Sterile: Manufactured by: Stryker Spine SAS, Ce recall (Z-0762-2010) | Stryker Spine | 2010-04-12 |
| Stryker Reflex Hybrid Screw Extractor Inner Shaft; Not Sterile; Manufactured by: Stryker S recall (Z-0763-2010) | Stryker Spine | 2010-04-12 |
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 |