Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K202022
GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE) · Medacta International S.A. · decided 2020-09-18 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| GMK Sphere Total Knee System | 02.12.E0611CRR | Medacta International SA | JWH | 07630971262263 |
| GMK Sphere Total Knee System | 02.12.E0313CRL | Medacta International SA | JWH | 07630971261617 |
| GMK Sphere Total Knee System | 02.12.E0111CRR | Medacta International SA | JWH | 07630971261068 |
| GMK Sphere Total Knee System | 02.12.E0513FR | Medacta International SA | JWH | 07630971262126 |
| GMK Sphere Total Knee System | 02.12.E0512CRR | Medacta International SA | JWH | 07630971262065 |
| GMK Sphere Total Knee System | 02.12.E0312FR | Medacta International SA | JWH | 07630971261600 |
| GMK Sphere Total Knee System | 02.12.E0610CRL | Medacta International SA | JWH | 07630971262218 |
| GMK Sphere Total Knee System | 02.12.E0413FL | Medacta International SA | JWH | 07630971261877 |
| GMK Sphere Total Knee System | 02.12.E0312FL | Medacta International SA | JWH | 07630971261594 |
| GMK Sphere Total Knee System | 02.12.E0210FR | Medacta International SA | JWH | 07630971261280 |
| GMK Sphere Total Knee System | 02.12.E0512FR | Medacta International SA | JWH | 07630971262089 |
| GMK Sphere Total Knee System | 02.12.E0312CRL | Medacta International SA | JWH | 07630971261570 |
| GMK Sphere Total Knee System | 02.12.E0610CRR | Medacta International SA | JWH | 07630971262225 |
| GMK Sphere Total Knee System | 02.12.E0511FR | Medacta International SA | JWH | 07630971262041 |
| GMK Sphere Total Knee System | 02.12.E0310CRL | Medacta International SA | JWH | 07630971261495 |
| GMK Sphere Total Knee System | 02.12.E0111CRL | Medacta International SA | JWH | 07630971261051 |
| GMK Sphere Total Knee System | 02.12.E0513FL | Medacta International SA | JWH | 07630971262119 |
| GMK Sphere Total Knee System | 02.12.E0210CRR | Medacta International SA | JWH | 07630971261266 |
| GMK Sphere Total Knee System | 02.12.E0612FL | Medacta International SA | JWH | 07630971262317 |
| GMK Sphere Total Knee System | 02.12.E0411CRR | Medacta International SA | JWH | 07630971261785 |
| GMK Sphere Total Knee System | 02.12.E0212FL | Medacta International SA | JWH | 07630971261358 |
| GMK Sphere Total Knee System | 02.12.E0113FL | Medacta International SA | JWH | 07630971261150 |
| GMK Sphere Total Knee System | 02.12.E0113CRR | Medacta International SA | JWH | 07630971261143 |
| GMK Sphere Total Knee System | 02.12.E0613FR | Medacta International SA | JWH | 07630971262362 |
| GMK Sphere Total Knee System | 02.12.E0510CRL | Medacta International SA | JWH | 07630971261976 |