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

Clearance record K123906

VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM · Medtronic Sofamor Danek USA, Inc. · decided 2013-04-01 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
VERTEX® Reconstruction System7753619MEDTRONIC SOFAMOR DANEK, INC.KWP00613994932433
VERTEX® Reconstruction System7753619AMEDTRONIC SOFAMOR DANEK, INC.KWP00643169096974
VERTEX® Reconstruction System7753919MEDTRONIC SOFAMOR DANEK, INC.KWP00643169098305