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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K253876

HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) · Globus Medical, Inc. · decided 2025-12-22 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
HEDRON1406.5809SGLOBUS MEDICAL, INC.ODP OVE00193982685577
HEDRON1406.5808SGLOBUS MEDICAL, INC.ODP OVE00193982685560
HEDRON1406.4610SGLOBUS MEDICAL, INC.ODP OVE00193982685126
HEDRON1406.4700SGLOBUS MEDICAL, INC.ODP OVE00193982685287
HEDRON1406.4675SGLOBUS MEDICAL, INC.ODP OVE00193982685157
HEDRON1406.2497SGLOBUS MEDICAL, INC.ODP OVE00193982684761
HEDRON1406.2406SGLOBUS MEDICAL, INC.ODP OVE00193982684594
HEDRON1406.4678SGLOBUS MEDICAL, INC.ODP OVE00193982685188
HEDRON1406.5807SGLOBUS MEDICAL, INC.ODP OVE00193982685553
HEDRON1406.4608SGLOBUS MEDICAL, INC.ODP OVE00193982685102
HEDRON1406.2475SGLOBUS MEDICAL, INC.ODP OVE00193982684662
HEDRON1406.2411SGLOBUS MEDICAL, INC.ODP OVE00193982684648
HEDRON1406.2407SGLOBUS MEDICAL, INC.ODP OVE00193982684600
HEDRON1406.4606SGLOBUS MEDICAL, INC.ODP OVE00193982685089
HEDRON1406.2499SGLOBUS MEDICAL, INC.ODP OVE00193982684785
HEDRON1406.2478SGLOBUS MEDICAL, INC.ODP OVE00193982684693
HEDRON1406.4679SGLOBUS MEDICAL, INC.ODP OVE00193982685195
HEDRON1406.5882SGLOBUS MEDICAL, INC.ODP OVE00193982685683
HEDRON1406.4702SGLOBUS MEDICAL, INC.ODP OVE00193982685300
HEDRON1406.2477SGLOBUS MEDICAL, INC.ODP OVE00193982684686
HEDRON1406.4676SGLOBUS MEDICAL, INC.ODP OVE00193982685164
HEDRON1406.5898SGLOBUS MEDICAL, INC.ODP OVE00193982685720
HEDRON1406.4699SGLOBUS MEDICAL, INC.ODP OVE00193982685270
HEDRON1406.5881SGLOBUS MEDICAL, INC.ODP OVE00193982685676
HEDRON1406.2496SGLOBUS MEDICAL, INC.ODP OVE00193982684754