Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K222270
HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments · Globus Medical, Inc. · decided 2022-10-21 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| EXCELSIUS GPS | 6252.1501 | GLOBUS MEDICAL, INC. | OLO | 00193982617288 |
| EXCELSIUS GPS | 6252.1526 | GLOBUS MEDICAL, INC. | OLO | 00193982617387 |
| EXCELSIUS GPS | 6252.1522 | GLOBUS MEDICAL, INC. | OLO | 00193982617370 |
| EXCELSIUS GPS | 6252.1519 | GLOBUS MEDICAL, INC. | OLO | 00193982617356 |
| EXCELSIUS GPS | 6252.1535 | GLOBUS MEDICAL, INC. | OLO | 00193982617417 |
| EXCELSIUS GPS | 6252.1518 | GLOBUS MEDICAL, INC. | OLO | 00193982617349 |
| EXCELSIUS GPS | 6252.1520 | GLOBUS MEDICAL, INC. | OLO | 00193982617363 |
| EXCELSIUS GPS | 6252.1502 | GLOBUS MEDICAL, INC. | OLO | 00193982617295 |
| EXCELSIUS GPS | 6252.1534 | GLOBUS MEDICAL, INC. | OLO | 00193982617400 |
| EXCELSIUS GPS | 6252.1530 | GLOBUS MEDICAL, INC. | OLO | 00193982617394 |