TRIO + SPINAL SYSTEM
FDA 510(k) clearance K062698 · decided 2006-10-11
Clearance details
- K-number
- K062698
- Device name
- TRIO + SPINAL SYSTEM
- Applicant
- Stryker Spine
- Decision
- Substantially Equivalent
- Date received
- 2006-09-11
- Decision date
- 2006-10-11
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- MNI
- 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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| Premier (K160320) | Shandong Weigao Orthopaedic Device Co., Ltd. | 2016-04-01 |
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| FIREFLY Pedicle Screw Navigation Guide (K143222) | Mighty Oak Medical, Inc. | 2015-12-11 |
| WASTON General Spinal System (K150684) | Changzhou Waston Medical Appliance Co., Ltd. | 2015-11-18 |
| X-spine Pedicle Screw System (K152132) | X-Spine Systems, Inc. | 2015-09-25 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW recall (Z-2235-2012) | Stryker Spine | 2012-08-22 |
| Stryker Trio Connector Hex Socket for Torque Wrench 3.5MM Not Sterile: Manufactured by: St recall (Z-1886-2009) | Stryker Spine | 2009-09-16 |
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 |