Smith & Nephew Richards, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 87
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K965224 | EMPOWER ANTERIOR DIRECT SCREWS | May 8, 1997 |
| K963509 | GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON | January 27, 1997 |
| K960444 | FINN ROD TO ROD CONNECTOR | January 24, 1997 |
| K964163 | TRIMAX NAIL SYSTEM | December 27, 1996 |
| K962557 | GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT | December 5, 1996 |
| K963486 | REVISION HIP SYSTEM | November 27, 1996 |
| K962541 | REFLECTION ACETABULAR REINFORCEMENT RINGS | September 17, 1996 |
| K962808 | ILIZAROV EXTERNAL FIXATION SYSTEM | August 19, 1996 |
| K962137 | GENESIS II CONSTRAINED SYSTEM | August 2, 1996 |
| K955767 | COFIED MODULAR SHOULDER SYSTEM | April 8, 1996 |
| K960094 | REFLECTION DUAL DIMENSION SHELL | March 27, 1996 |
| K954696 | ROGOZINSKI THORACOLUMBAR SPINAL ROD | March 11, 1996 |
| K953274 | GENESIS POROUS TIBIAL TRAYS & REVISION KNEE SYSTEM | February 5, 1996 |
| K954909 | PROFIX POSTERIOR-STABILIZED KNEE SYSTEM | January 31, 1996 |
| K955552 | EXPRESSAIRE TORUNIQUET SYSTEM | January 5, 1996 |
| K954491 | HYDROCELL NASAL AND SINUS PACKS | November 15, 1995 |
| K953397 | HEX-FIX FIELD FIXATOR | October 31, 1995 |
| K954712 | INTRAMEDULLARY HIP SCREW (MODIFICATION) | October 31, 1995 |
| K952697 | TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM | September 12, 1995 |
| K952271 | GENESIS CONSTRAINED SYSTEM (GCS) | September 8, 1995 |