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

Clearance record K182119

CD HORIZON™ Spinal System · Medtronic Sofamor Danek USA, Inc. · decided 2018-08-29 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
CD HORIZON® Spinal SystemG5932004747MEDTRONIC SOFAMOR DANEK, INC.KWP00763000584313
CD HORIZON® Spinal SystemGX0617046MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000048204
CD HORIZON® Spinal SystemG5932005656MEDTRONIC SOFAMOR DANEK, INC.KWP00763000584337
CD HORIZON® Spinal SystemGX0617049MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000048235
CD HORIZON® Spinal SystemGX0617043MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000048174
CD HORIZON® Spinal SystemGX0617052MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000048266
CD HORIZON® Spinal SystemG5932004756MEDTRONIC SOFAMOR DANEK, INC.KWP00763000584320
CD HORIZON® Spinal SystemG5932105656MEDTRONIC SOFAMOR DANEK, INC.KWP00763000584344