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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)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
EXCELSIUS GPS6252.1501GLOBUS MEDICAL, INC.OLO00193982617288
EXCELSIUS GPS6252.1526GLOBUS MEDICAL, INC.OLO00193982617387
EXCELSIUS GPS6252.1522GLOBUS MEDICAL, INC.OLO00193982617370
EXCELSIUS GPS6252.1519GLOBUS MEDICAL, INC.OLO00193982617356
EXCELSIUS GPS6252.1535GLOBUS MEDICAL, INC.OLO00193982617417
EXCELSIUS GPS6252.1518GLOBUS MEDICAL, INC.OLO00193982617349
EXCELSIUS GPS6252.1520GLOBUS MEDICAL, INC.OLO00193982617363
EXCELSIUS GPS6252.1502GLOBUS MEDICAL, INC.OLO00193982617295
EXCELSIUS GPS6252.1534GLOBUS MEDICAL, INC.OLO00193982617400
EXCELSIUS GPS6252.1530GLOBUS MEDICAL, INC.OLO00193982617394