Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K093944
MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA S · Medacta International S.A. · decided 2010-01-21 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Quadra H femoral stems | 01.12.29SN | Medacta International SA | LZO MEH | 07630030802690 |
| AMIStem H Femoral Stems | 01.18.134 | Medacta International SA | LZO MEH | 07630030804106 |
| Quadra H femoral stems | 01.12.24SN | Medacta International SA | LZO MEH | 07630030802645 |
| AMIStem H Femoral Stems | 01.18.139 | Medacta International SA | LZO MEH | 07630030804151 |
| AMIStem H Femoral Stems | 01.18.143 | Medacta International SA | LZO MEH | 07630030804199 |
| Quadra S femoral stems | 01.12.05SN | Medacta International SA | LZO MEH | 07630030802379 |
| Quadra S femoral stems | 01.12.08SN | Medacta International SA | LZO MEH | 07630030802508 |
| AMIStem H Femoral Stems | 01.18.141 | Medacta International SA | LZO MEH | 07630030804175 |
| Quadra H femoral stems | 01.12.26SN | Medacta International SA | LZO MEH | 07630030802669 |
| AMIStem H Femoral Stems | 01.18.132 | Medacta International SA | LZO MEH | 07630030804083 |
| AMIStem H Femoral Stems | 01.18.148 | Medacta International SA | LZO MEH | 07630030804243 |
| AMIStem H Femoral Stems | 01.18.135 | Medacta International SA | LZO MEH | 07630030804113 |
| AMIStem H Femoral Stems | 01.18.130 | Medacta International SA | LZO MEH | 07630030804069 |
| Quadra H femoral stems | 01.12.27SN | Medacta International SA | LZO MEH | 07630030802676 |
| Quadra S femoral stems | 01.12.09SN | Medacta International SA | LZO MEH | 07630030802515 |
| Quadra H femoral stems | 01.12.34SN | Medacta International SA | LZO MEH | 07630030802744 |
| AMIStem H Femoral Stems | 01.18.133 | Medacta International SA | LZO MEH | 07630030804090 |
| Quadra H femoral stems | 01.12.25SN | Medacta International SA | LZO MEH | 07630030802652 |
| AMIStem H Femoral Stems | 01.18.145 | Medacta International SA | LZO MEH | 07630030804212 |
| Quadra S femoral stems | 01.12.15SN | Medacta International SA | LZO MEH | 07630030802577 |
| AMIStem H Femoral Stems | 01.18.142 | Medacta International SA | LZO MEH | 07630030804182 |
| AMIStem H Femoral Stems | 01.18.137 | Medacta International SA | LZO MEH | 07630030804137 |
| Quadra S femoral stems | 01.12.07SN | Medacta International SA | LZO MEH | 07630030802492 |
| Quadra S femoral stems | 01.12.04SN | Medacta International SA | LZO MEH | 07630030802294 |
| Quadra H femoral stems | 01.12.35SN | Medacta International SA | LZO MEH | 07630030802751 |