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

Clearance record K163375

INFINITY™ OCT System · Medtronic Sofamor Danek USA, Inc. · decided 2017-08-21 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
INFINITY™ Occipitocervical Upper Thoracic System3604032MEDTRONIC SOFAMOR DANEK, INC.KWP NKG00643169554726
INFINITY™ Occipitocervical Upper Thoracic SystemG3606071MEDTRONIC SOFAMOR DANEK, INC.KWP NKG00643169549661
INFINITY™ Occipitocervical Upper Thoracic SystemG3604512MEDTRONIC SOFAMOR DANEK, INC.KWP NKG00643169541412
INFINITY™ Occipitocervical Upper Thoracic System3602516AMEDTRONIC SOFAMOR DANEK, INC.KWP NKG00643169555372
INFINITY™ Occipitocervical Upper Thoracic SystemG3600300MEDTRONIC SOFAMOR DANEK, INC.KWP NKG00643169543201
INFINITY™ Occipitocervical Upper Thoracic SystemG360PT3536MEDTRONIC SOFAMOR DANEK, INC.KWP NKG00643169542068
INFINITY™ Occipitocervical Upper Thoracic System3601350MEDTRONIC SOFAMOR DANEK, INC.KWP NKG00643169527768
INFINITY™ Occipitocervical Upper Thoracic System3600211MEDTRONIC SOFAMOR DANEK, INC.KWP NKG00643169624160
INFINITY™ Occipitocervical Upper Thoracic SystemG3602519AMEDTRONIC SOFAMOR DANEK, INC.KWP NKG00643169549760
INFINITY™ Occipitocervical Upper Thoracic System3603350MEDTRONIC SOFAMOR DANEK, INC.KWP NKG00643169527829
INFINITY™ Occipitocervical Upper Thoracic System360PT4040MEDTRONIC SOFAMOR DANEK, INC.KWP NKG00643169552746
INFINITY™ Occipitocervical Upper Thoracic System360PT4034MEDTRONIC SOFAMOR DANEK, INC.KWP NKG00643169552715
INFINITY™ Occipitocervical Upper Thoracic SystemG3603538MEDTRONIC SOFAMOR DANEK, INC.KWP NKG00643169542365
INFINITY™ Occipitocervical Upper Thoracic SystemG3604032MEDTRONIC SOFAMOR DANEK, INC.KWP NKG00643169542563
INFINITY™ Occipitocervical Upper Thoracic SystemG3603526MEDTRONIC SOFAMOR DANEK, INC.KWP NKG00643169542303
INFINITY™ Occipitocervical Upper Thoracic System3604522MEDTRONIC SOFAMOR DANEK, INC.KWP NKG00643169541801
INFINITY™ Occipitocervical Upper Thoracic System3604020MEDTRONIC SOFAMOR DANEK, INC.KWP NKG00643169554665
INFINITY™ Occipitocervical Upper Thoracic SystemG3600412MEDTRONIC SOFAMOR DANEK, INC.KWP NKG00643169543010
INFINITY™ Occipitocervical Upper Thoracic System3607010MEDTRONIC SOFAMOR DANEK, INC.KWP NKG00643169839434
INFINITY™ Occipitocervical Upper Thoracic System3603520MEDTRONIC SOFAMOR DANEK, INC.KWP NKG00643169554436
INFINITY™ Occipitocervical Upper Thoracic System3603760MEDTRONIC SOFAMOR DANEK, INC.KWP NKG00643169624085
INFINITY™ Occipitocervical Upper Thoracic System3603508MEDTRONIC SOFAMOR DANEK, INC.KWP NKG00643169554375
INFINITY™ Occipitocervical Upper Thoracic System3603028MEDTRONIC SOFAMOR DANEK, INC.KWP NKG00643169528611
INFINITY™ Occipitocervical Upper Thoracic System360PT3526MEDTRONIC SOFAMOR DANEK, INC.KWP NKG00643169552555
INFINITY™ Occipitocervical Upper Thoracic System3604526MEDTRONIC SOFAMOR DANEK, INC.KWP NKG00643169541825