Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K103189
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK · Medacta International S.A. · decided 2010-12-20 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| AMIStem C Femoral Stems | 01.18.103 | Medacta International SA | JDI LZO | 07630030803819 |
| Quadra C Femoral Stems | 01.12.44SN | Medacta International SA | JDI LZO | 07630030802829 |
| AMIStem C Femoral Stems | 01.18.157 | Medacta International SA | JDI LZO | 07630030804328 |
| AMIStem C Femoral Stems | 01.18.153 | Medacta International SA | JDI LZO | 07630030804281 |
| Quadra C Femoral Stems | 01.12.47SN | Medacta International SA | JDI LZO | 07630030802850 |
| Quadra C Femoral Stems | 01.12.45SN | Medacta International SA | JDI LZO | 07630030802836 |
| Quadra C Femoral Stems | 01.12.56SN | Medacta International SA | JDI LZO | 07630030802911 |
| AMIStem C Femoral Stems | 01.18.158 | Medacta International SA | JDI LZO | 07630030804335 |
| Quadra C Femoral Stems | 01.12.40SN | Medacta International SA | JDI LZO | 07630030802782 |
| Quadra C Femoral Stems | 01.12.42SN | Medacta International SA | JDI LZO | 07630030802805 |
| AMIStem C Femoral Stems | 01.18.101 | Medacta International SA | JDI LZO | 07630030803796 |
| AMIStem C Femoral Stems | 01.18.106 | Medacta International SA | JDI LZO | 07630030803840 |
| Quadra C Femoral Stems | 01.12.51SN | Medacta International SA | JDI LZO | 07630030802867 |
| AMIStem C Femoral Stems | 01.18.108 | Medacta International SA | JDI LZO | 07630030803864 |
| AMIStem C Femoral Stems | 01.18.105 | Medacta International SA | JDI LZO | 07630030803833 |
| Quadra C Femoral Stems | 01.12.41SN | Medacta International SA | JDI LZO | 07630030802799 |
| AMIStem C Femoral Stems | 01.18.155 | Medacta International SA | JDI LZO | 07630030804304 |
| Quadra C Femoral Stems | 01.12.52SN | Medacta International SA | JDI LZO | 07630030802874 |
| AMIStem C Femoral Stems | 01.18.154 | Medacta International SA | JDI LZO | 07630030804298 |
| AMIStem C Femoral Stems | 01.18.152 | Medacta International SA | JDI LZO | 07630030804274 |
| AMIStem C Femoral Stems | 01.18.150 | Medacta International SA | JDI LZO | 07630030804250 |
| Quadra C Femoral Stems | 01.12.43SN | Medacta International SA | JDI LZO | 07630030802812 |
| Quadra C Femoral Stems | 01.12.57SN | Medacta International SA | JDI LZO | 07630030802928 |
| AMIStem C Femoral Stems | 01.18.151 | Medacta International SA | JDI LZO | 07630030804267 |
| AMIStem C Femoral Stems | 01.18.100 | Medacta International SA | JDI LZO | 07630030803789 |