Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K112115
MECTACER BIOLOX(R) DELTA FEMORAL HEADS · Medacta International · decided 2011-10-07 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Mectacer Biolox Delta Femoral Ball Head | 01.29.211 | Medacta International SA | LZO | 07630030809224 |
| Mectacer Biolox Delta Femoral Ball Head | 01.29.218 | Medacta International SA | LZO | 07630030809293 |
| Mectacer Biolox Delta Femoral Ball Head | 01.29.206 | Medacta International SA | LZO | 07630030809170 |
| Mectacer Biolox Delta Femoral Ball Head | 01.29.212 | Medacta International SA | LZO | 07630030809231 |
| Mectacer Biolox Delta Femoral Ball Head | 01.29.219 | Medacta International SA | LZO | 07630030809309 |
| Mectacer Biolox Delta Femoral Ball Head | 01.29.204 | Medacta International SA | LZO | 07630030809156 |
| Mectacer Biolox Delta Femoral Ball Head | 01.29.202 | Medacta International SA | LZO | 07630030809132 |
| Mectacer Biolox Delta Femoral Ball Head | 01.29.213 | Medacta International SA | LZO | 07630030809248 |
| Mectacer Biolox Delta Femoral Ball Head | 01.29.207 | Medacta International SA | LZO | 07630030809187 |
| Mectacer Biolox Delta Femoral Ball Head | 01.29.215 | Medacta International SA | LZO | 07630030809262 |
| Mectacer Biolox Delta Femoral Ball Head | 01.29.205 | Medacta International SA | LZO | 07630030809163 |
| Mectacer Biolox Delta Femoral Ball Head | 01.29.201 | Medacta International SA | LZO | 07630030809125 |
| Mectacer Biolox Delta Femoral Ball Head | 01.29.214 | Medacta International SA | LZO | 07630030809255 |
| Mectacer Biolox Delta Femoral Ball Head | 01.29.209 | Medacta International SA | LZO | 07630030809200 |
| Mectacer Biolox Delta Femoral Ball Head | 01.29.208 | Medacta International SA | LZO | 07630030809194 |
| Mectacer Biolox Delta Femoral Ball Head | 01.29.216 | Medacta International SA | LZO | 07630030809279 |
| Mectacer Biolox Delta Femoral Ball Head | 01.29.203 | Medacta International SA | LZO | 07630030809149 |
| Mectacer Biolox Delta Femoral Ball Head | 01.29.210 | Medacta International SA | LZO | 07630030809217 |
| Mectacer Biolox Delta Femoral Ball Head | 01.29.217 | Medacta International SA | LZO | 07630030809286 |