Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Quadra R femoral stems | 01.12.068 | Medacta International SA | JDI | 07630030802461 |
| Quadra H femoral stems | 01.12.20SN | Medacta International SA | JDI | 07630030802607 |
| Quadra R femoral stems | 01.12.069 | Medacta International SA | JDI | 07630030802478 |
| Quadra H femoral stems | 01.12.32SN | Medacta International SA | JDI | 07630030802720 |
| Quadra H femoral stems | 01.12.034 | Medacta International SA | JDI | 07630030802164 |
| Quadra H femoral stems | 01.12.026 | Medacta International SA | JDI | 07630030802072 |
| Quadra R femoral stems | 01.12.063 | Medacta International SA | JDI | 07630030802416 |
| Quadra R femoral stems | 01.12.066 | Medacta International SA | JDI | 07630030802447 |
| Quadra H femoral stems | 01.12.23SN | Medacta International SA | JDI | 07630030802638 |
| Quadra H femoral stems | 01.12.028 | Medacta International SA | JDI | 07630030802096 |
| Quadra H femoral stems | 01.12.032 | Medacta International SA | JDI | 07630030802140 |
| Quadra H femoral stems | 01.12.035 | Medacta International SA | JDI | 07630030802171 |
| Quadra R femoral stems | 01.12.061 | Medacta International SA | JDI | 07630030802393 |
| Quadra H femoral stems | 01.12.024 | Medacta International SA | JDI | 07630030802058 |
| Quadra H femoral stems | 01.12.020 | Medacta International SA | JDI | 07630030802010 |
| Quadra H femoral stems | 01.12.022 | Medacta International SA | JDI | 07630030802034 |
| Quadra H femoral stems | 01.12.033 | Medacta International SA | JDI | 07630030802157 |
| Quadra H femoral stems | 01.12.22SN | Medacta International SA | JDI | 07630030802621 |
| Quadra H femoral stems | 01.12.025 | Medacta International SA | JDI | 07630030802065 |
| Quadra H femoral stems | 01.12.027 | Medacta International SA | JDI | 07630030802089 |
| Quadra H femoral stems | 01.12.030 | Medacta International SA | JDI | 07630030802126 |
| Quadra H femoral stems | 01.12.029 | Medacta International SA | JDI | 07630030802102 |
| Quadra H femoral stems | 01.12.023 | Medacta International SA | JDI | 07630030802041 |
| Quadra R femoral stems | 01.12.064 | Medacta International SA | JDI | 07630030802423 |
| Quadra H femoral stems | 01.12.21SN | Medacta International SA | JDI | 07630030802614 |