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

Clearance record K123568

VERTEX RECONSTRUCTION SYSTEM · Medtronic Sofamor Danek USA, Inc. · decided 2012-12-18 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
VERTEX® Reconstruction SystemX1111088MEDTRONIC SOFAMOR DANEK, INC.KWP00643169108691
VERTEX® Reconstruction SystemX1111085MEDTRONIC SOFAMOR DANEK, INC.KWP00643169108660
VERTEX® Reconstruction SystemX1111084MEDTRONIC SOFAMOR DANEK, INC.KWP00643169108653
VERTEX® Reconstruction SystemX1111083MEDTRONIC SOFAMOR DANEK, INC.KWP00643169108646
VERTEX® Reconstruction SystemX1111086MEDTRONIC SOFAMOR DANEK, INC.KWP00643169108677
VERTEX® Reconstruction SystemX1111089MEDTRONIC SOFAMOR DANEK, INC.KWP00643169108707
VERTEX® Reconstruction SystemX1111082MEDTRONIC SOFAMOR DANEK, INC.KWP00643169108639
VERTEX® Reconstruction SystemX1111087MEDTRONIC SOFAMOR DANEK, INC.KWP00643169108684