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

Clearance record K121191

VERTEX RCCONSTRUCTION SYSTEM · Medtronic Sofamor Danek, Inc. · decided 2012-06-29 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
VERTEX® Reconstruction SystemX0508075MEDTRONIC SOFAMOR DANEK, INC.KWP00613994531759
CD HORIZON® Spinal SystemX0508080MEDTRONIC SOFAMOR DANEK, INC.KWP00613994531803
VERTEX® Reconstruction SystemX0508076MEDTRONIC SOFAMOR DANEK, INC.KWP00613994531766
VERTEX® Reconstruction SystemX0508077MEDTRONIC SOFAMOR DANEK, INC.KWP00613994531773
VERTEX® Reconstruction SystemX0508079MEDTRONIC SOFAMOR DANEK, INC.KWP00613994531797
VERTEX® Reconstruction SystemX0508078MEDTRONIC SOFAMOR DANEK, INC.KWP00613994531780