Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K161665
VLP Wrist Fracture System · Smith & Nephew, Inc. · decided 2016-11-15 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| VLP | 74403512 | Smith & Nephew, Inc. | HRS HWC | 00885556630990 |
| D-RAD | 71158052 | Smith & Nephew, Inc. | HRS HWC | 00885556631355 |
| VLP | 74413512 | Smith & Nephew, Inc. | HRS HWC | 00885556631157 |
| D-RAD | 71158048 | Smith & Nephew, Inc. | HRS HWC | 00885556631317 |
| D-RAD | 71158047 | Smith & Nephew, Inc. | HRS HWC | 00885556631300 |
| VLP | 74403530 | Smith & Nephew, Inc. | HRS HWC | 00885556631102 |
| VLP | 74413513 | Smith & Nephew, Inc. | HRS HWC | 00885556631164 |
| VLP | 74403510 | Smith & Nephew, Inc. | HRS HWC | 00885556630976 |
| VLP | 74413510 | Smith & Nephew, Inc. | HRS HWC | 00885556631133 |
| D-RAD | 71158050 | Smith & Nephew, Inc. | HRS HWC | 00885556631331 |
| VLP | 74413522 | Smith & Nephew, Inc. | HRS HWC | 00885556631225 |
| VLP | 74403515 | Smith & Nephew, Inc. | HRS HWC | 00885556631027 |
| VLP | 74413516 | Smith & Nephew, Inc. | HRS HWC | 00885556631195 |
| VLP | 74403524 | Smith & Nephew, Inc. | HRS HWC | 00885556631072 |
| D-RAD | 71158041 | Smith & Nephew, Inc. | HRS HWC | 00885556630631 |
| D-RAD | 71158051 | Smith & Nephew, Inc. | HRS HWC | 00885556631348 |
| D-RAD | 71158039 | Smith & Nephew, Inc. | HRS HWC | 00885556630617 |
| VLP | 74403511 | Smith & Nephew, Inc. | HRS HWC | 00885556630983 |
| VLP | 74413524 | Smith & Nephew, Inc. | HRS HWC | 00885556631232 |
| VLP | 74403513 | Smith & Nephew, Inc. | HRS HWC | 00885556631003 |
| VLP | 74413515 | Smith & Nephew, Inc. | HRS HWC | 00885556631188 |
| D-RAD | 71158038 | Smith & Nephew, Inc. | HRS HWC | 00885556630600 |
| VLP | 74403522 | Smith & Nephew, Inc. | HRS HWC | 00885556631065 |
| VLP | 74413520 | Smith & Nephew, Inc. | HRS HWC | 00885556631218 |
| VLP | 74413511 | Smith & Nephew, Inc. | HRS HWC | 00885556631140 |