Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K201336
DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm · Synthes (USA) Products, LLC · decided 2020-09-03 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| (unnamed) | 04.045.248TS | Synthes GmbH | HWC JDS | 10886982301789 |
| (unnamed) | 04.045.522TS | Synthes GmbH | HWC JDS | 10886982301185 |
| (unnamed) | 04.043.135S | Synthes GmbH | HWC JDS | 10886982297631 |
| (unnamed) | 04.045.395TS | Synthes GmbH | HSB HWC JDS | 10886982302403 |
| (unnamed) | 04.045.572TS | Synthes GmbH | HWC JDS | 10886982301581 |
| (unnamed) | 04.045.036S | Synthes GmbH | HSB HWC JDS | 10886982294401 |
| (unnamed) | 04.045.246S | Synthes GmbH | HWC JDS | 10886982295187 |
| (unnamed) | 04.045.110S | Synthes GmbH | HSB HWC JDS | 10886982294715 |
| (unnamed) | 04.045.095S | Synthes GmbH | HSB HWC JDS | 10886982294685 |
| (unnamed) | 04.045.062TS | Synthes GmbH | HSB HWC JDS | 10886982302786 |
| (unnamed) | 04.043.355S | Synthes GmbH | HWC JDS | 10886982298270 |
| (unnamed) | 04.045.578 | Synthes GmbH | HWC JDS | 10886982294036 |
| (unnamed) | 04.045.060TS | Synthes GmbH | HSB HWC JDS | 10886982302779 |
| (unnamed) | 04.045.272TS | Synthes GmbH | HWC JDS | 10886982301901 |
| (unnamed) | 04.045.556TS | Synthes GmbH | HWC JDS | 10886982301505 |
| (unnamed) | 04.045.360S | Synthes GmbH | HSB HWC JDS | 10886982295088 |
| (unnamed) | 04.045.336S | Synthes GmbH | HSB HWC JDS | 10886982294968 |
| (unnamed) | 04.045.540 | Synthes GmbH | HWC JDS | 10886982294142 |
| (unnamed) | 04.045.526TS | Synthes GmbH | HWC JDS | 10886982301208 |
| (unnamed) | 04.045.244TS | Synthes GmbH | HWC JDS | 10886982300997 |
| (unnamed) | 04.045.234TS | Synthes GmbH | HWC JDS | 10886982300942 |
| (unnamed) | 04.043.570S | Synthes GmbH | HWC JDS | 10886982298003 |
| (unnamed) | 04.043.515S | Synthes GmbH | HWC JDS | 10886982297891 |
| (unnamed) | 04.043.250S | Synthes GmbH | HWC JDS | 10886982297815 |
| (unnamed) | 04.043.110S | Synthes GmbH | HWC JDS | 10886982297587 |