Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K173794
AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared · Medacta International S.A. · decided 2018-03-14 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| AMIStem-P Collared | 01.18.434 | Medacta International SA | KWY LPH LZO LZY MEH | 07630040720236 |
| AMIStem-P | 01.18.410 | Medacta International SA | KWY LPH LZO LZY MEH | 07630040720090 |
| AMIStem-P Collared | 01.18.432 | Medacta International SA | KWY LPH LZO LZY MEH | 07630040720212 |
| AMIStem-P Collared | 01.18.431 | Medacta International SA | KWY LPH LZO LZY MEH | 07630040720205 |
| AMIStem-P | 01.18.416 | Medacta International SA | KWY LPH LZO LZY MEH | 07630040720151 |
| AMIStem-P | 01.18.411 | Medacta International SA | KWY LPH LZO LZY MEH | 07630040720106 |
| AMIStem-P Collared | 01.18.429 | Medacta International SA | KWY LPH LZO LZY MEH | 07630040720182 |
| AMIStem-P Collared | 01.18.439 | Medacta International SA | KWY LPH LZO LZY MEH | 07630040720281 |
| AMIStem-P Collared | 01.18.435 | Medacta International SA | KWY LPH LZO LZY MEH | 07630040720243 |
| AMIStem-P | 01.18.408 | Medacta International SA | KWY LPH LZO LZY MEH | 07630040720076 |
| AMIStem-P | 01.18.412 | Medacta International SA | KWY LPH LZO LZY MEH | 07630040720113 |
| AMIStem-P | 01.18.403 | Medacta International SA | KWY LPH LZO LZY MEH | 07630040720021 |
| AMIStem-P Collared | 01.18.433 | Medacta International SA | KWY LPH LZO LZY MEH | 07630040720229 |
| AMIStem-P | 01.18.409 | Medacta International SA | KWY LPH LZO LZY MEH | 07630040720083 |
| AMIStem-P Collared | 01.18.436 | Medacta International SA | KWY LPH LZO LZY MEH | 07630040720250 |
| AMIStem-P Collared | 01.18.447 | Medacta International SA | KWY LPH LZO LZY MEH | 07630040720366 |
| AMIStem-P Collared | 01.18.430 | Medacta International SA | KWY LPH LZO LZY MEH | 07630040720199 |
| AMIStem-P | 01.18.401 | Medacta International SA | KWY LPH LZO LZY MEH | 07630040720007 |
| AMIStem-P | 01.18.402 | Medacta International SA | KWY LPH LZO LZY MEH | 07630040720014 |
| AMIStem-P | 01.18.399 | Medacta International SA | KWY LPH LZO LZY MEH | 07630040719988 |
| AMIStem-H Proximal Coating | 01.18.169 | Medacta International SA | KWY LPH LZO LZY MEH | 07630030804342 |
| AMIStem-P Collared | 01.18.443 | Medacta International SA | KWY LPH LZO LZY MEH | 07630040720328 |
| AMIStem-P | 01.18.405 | Medacta International SA | KWY LPH LZO LZY MEH | 07630040720045 |
| AMIStem-P Collared | 01.18.438 | Medacta International SA | KWY LPH LZO LZY MEH | 07630040720274 |
| AMIStem-H Proximal Coating | 01.18.180 | Medacta International SA | KWY LPH LZO LZY MEH | 07630030804458 |