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

Clearance record K143471

VERTEX Reconstruction System · Medtronic Sofamor Danek USA, Inc. · decided 2015-02-06 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
CD HORIZON® Spinal System25000065MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ MNH MNI NKB OLO OSH00643169414600