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

Clearance record K191243

HEDRON Cervical Spacers · Globus Medical, Inc. · decided 2019-09-17 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
HEDRON1211.2451SGLOBUS MEDICAL, INC.ODP00193982136970
HEDRON1213.6089SGLOBUS MEDICAL, INC.ODP OVE00193982127305
HEDRON1213.6011SGLOBUS MEDICAL, INC.ODP OVE00193982126940
HEDRON1211.5829SGLOBUS MEDICAL, INC.ODP00193982140168
HEDRON1211.4629SGLOBUS MEDICAL, INC.ODP00193982138516
HEDRON1211.4616SGLOBUS MEDICAL, INC.ODP00193982138394
HEDRON1211.5828SGLOBUS MEDICAL, INC.ODP00193982140151
HEDRON1211.2439SGLOBUS MEDICAL, INC.ODP00193982136871
HEDRON1213.6082SGLOBUS MEDICAL, INC.ODP OVE00193982127251
HEDRON1211.5838SGLOBUS MEDICAL, INC.ODP00193982140236
HEDRON1213.8008SGLOBUS MEDICAL, INC.ODP OVE00193982128197
HEDRON1211.5805SGLOBUS MEDICAL, INC.ODP00193982139933
HEDRON1211.4630SGLOBUS MEDICAL, INC.ODP00193982138523
HEDRON1213.8092SGLOBUS MEDICAL, INC.ODP OVE00193982128616
HEDRON1213.8011SGLOBUS MEDICAL, INC.ODP OVE00193982128227
HEDRON1211.5809SGLOBUS MEDICAL, INC.ODP00193982139971
HEDRON1213.4089SGLOBUS MEDICAL, INC.ODP OVE00193982125981
HEDRON1213.4086SGLOBUS MEDICAL, INC.ODP OVE00193982125950
HEDRON1213.8012SGLOBUS MEDICAL, INC.ODP OVE00193982128234
HEDRON1211.4651SGLOBUS MEDICAL, INC.ODP00193982138684
HEDRON1211.2422SGLOBUS MEDICAL, INC.ODP00193982136727
HEDRON1213.8085SGLOBUS MEDICAL, INC.ODP OVE00193982128548
HEDRON1213.6008SGLOBUS MEDICAL, INC.ODP OVE00193982126919
HEDRON1211.4615SGLOBUS MEDICAL, INC.ODP00193982138387
HEDRON1211.5807SGLOBUS MEDICAL, INC.ODP00193982139957