Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K210912
Excelsius3D · Globus Medical, Inc. · decided 2021-08-12 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| EXCELSIUS3D | 6161.1000 | GLOBUS MEDICAL, INC. | JAA OWB OXO | 00193982184506 |
| EXCELSIUS3D | 6161.2100 | GLOBUS MEDICAL, INC. | JAA OWB OXO | 00193982184537 |