Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K211004
GMK Spherika Femurs and Fixed Tibial Trays Plus · Medacta International S.A. · decided 2021-05-13 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| GMK Total Knee System | 02.12.KA65L | Medacta International SA | JWH | 07630345723963 |
| GMK Total Knee System | 02.12.KA31R | Medacta International SA | JWH | 07630345716446 |
| GMK Total Knee System | 02.12.KA23R | Medacta International SA | JWH | 07630345716347 |
| GMK Total Knee System | 02.12.KA55R | Medacta International SA | JWH | 07630345723857 |
| GMK Total Knee System | 02.07.12045R | Medacta International SA | JWH | 07630345729576 |
| GMK Total Knee System | 02.12.KA62L | Medacta International SA | JWH | 07630345723901 |
| GMK Total Knee System | 02.12.KA27R | Medacta International SA | JWH | 07630345716422 |
| GMK Total Knee System | 02.12.KA35R | Medacta International SA | JWH | 07630345716521 |
| GMK Total Knee System | 02.12.KA32L | Medacta International SA | JWH | 07630345716453 |
| GMK Total Knee System | 02.12.KA13L | Medacta International SA | JWH | 07630345716217 |
| GMK Total Knee System | 02.12.KA61R | Medacta International SA | JWH | 07630345723895 |
| GMK Total Knee System | 02.12.KA46L | Medacta International SA | JWH | 07630345723727 |
| GMK Total Knee System | 02.12.KA27L | Medacta International SA | JWH | 07630345716415 |
| GMK Total Knee System | 02.12.T35I4R | Medacta International SA | JWH | 07630345730992 |
| GMK Total Knee System | 02.07.12015L | Medacta International SA | JWH | 07630345729507 |
| GMK Total Knee System | 02.12.KA14R | Medacta International SA | JWH | 07630345716248 |
| GMK Total Knee System | 02.12.KA71L | Medacta International SA | JWH | 07630345724021 |
| GMK Total Knee System | 02.07.12055L | Medacta International SA | JWH | 07630345729583 |
| GMK Total Knee System | 02.12.KA73R | Medacta International SA | JWH | 07630345724076 |
| GMK Total Knee System | 02.12.KA51L | Medacta International SA | JWH | 07630345723765 |
| GMK Total Knee System | 02.12.KA31L | Medacta International SA | JWH | 07630345716439 |
| GMK Total Knee System | 02.12.KA12R | Medacta International SA | JWH | 07630345716200 |
| GMK Total Knee System | 02.12.KA54R | Medacta International SA | JWH | 07630345723833 |
| GMK Total Knee System | 02.12.KA53L | Medacta International SA | JWH | 07630345723802 |
| GMK Total Knee System | 02.12.KA74L | Medacta International SA | JWH | 07630345724083 |