Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K211664
GMK Sphere Revision · Medacta International S.A. · decided 2021-07-29 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| GMK Sphere Revision System | 02.19.005L | Medacta International SA | JWH | 07630971243255 |
| GMK Sphere Revision System | 02.19.016R | Medacta International SA | JWH | 07630345718297 |
| GMK Sphere Revision System | 02.19.DC16 | Medacta International SA | JWH | 07630345718839 |
| GMK Sphere Revision System | 02.19.T4I3R | Medacta International SA | JWH | 07630345719119 |
| GMK Sphere Revision System | 02.19.PB12 | Medacta International SA | JWH | 07630345718952 |
| GMK Sphere Revision System | 02.19.PE08 | Medacta International SA | JWH | 07630345719034 |
| GMK Sphere Revision System | 02.19.015L | Medacta International SA | JWH | 07630345718266 |
| GMK Sphere Revision System | 02.19.008R | Medacta International SA | JWH | 07630971243323 |
| GMK Sphere Revision System | 02.19.PF12 | Medacta International SA | JWH | 07630345719072 |
| GMK Sphere Revision System | 02.19.PD08 | Medacta International SA | JWH | 07630345719003 |
| GMK Sphere Revision System | 02.19.004L | Medacta International SA | JWH | 07630971243231 |
| GMK Sphere Revision System | 02.19.006R | Medacta International SA | JWH | 07630971243286 |
| GMK Sphere Revision System | 02.19.014L | Medacta International SA | JWH | 07630345718242 |
| GMK Sphere Revision System | 02.19.DA16 | Medacta International SA | JWH | 07630345718730 |
| GMK Sphere Revision System | 02.19.DC08 | Medacta International SA | JWH | 07630345718815 |
| GMK Sphere Revision System | 02.19.DA04 | Medacta International SA | JWH | 07630345718709 |
| GMK Sphere Revision System | 02.19.DD20 | Medacta International SA | JWH | 07630345718891 |
| GMK Sphere Revision System | 02.19.015R | Medacta International SA | JWH | 07630345718273 |
| GMK Sphere Revision System | 02.19.PF04 | Medacta International SA | JWH | 07630345719058 |
| GMK Sphere Revision System | 02.19.DB12 | Medacta International SA | JWH | 07630345718778 |
| GMK Sphere Revision System | 02.19.DA12 | Medacta International SA | JWH | 07630345718723 |
| GMK Sphere Revision System | 02.19.DB20 | Medacta International SA | JWH | 07630345718792 |
| GMK Sphere Revision System | 02.19.T4I3L | Medacta International SA | JWH | 07630345719102 |
| GMK Sphere Revision System | 02.19.28T3I4R | Medacta International SA | JWH | 07630345718679 |
| GMK Sphere Revision System | 02.19.PD12 | Medacta International SA | JWH | 07630345719010 |