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

Clearance record K143019

CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · decided 2015-04-08 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
CD HORIZON® Spinal SystemX1013185MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ MNH MNI NKB OSH00643169465824
CD HORIZON® Spinal SystemX1013194MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ MNH MNI NKB OSH00643169465732
CD HORIZON® Spinal SystemX1013192MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ MNH MNI NKB OSH00643169465756
CD HORIZON® Spinal SystemX1013216MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ MNH MNI NKB OSH00643169468771
CD HORIZON® Spinal SystemX1013191MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ MNH MNI NKB OSH00643169465763
CD HORIZON® Spinal SystemX1013213MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ MNH MNI NKB OSH00643169468740
CD HORIZON® Spinal SystemX1013188MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ MNH MNI NKB OSH00643169465794
CD HORIZON® Spinal SystemX1013211MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ MNH MNI NKB OSH00643169468726
CD HORIZON® Spinal SystemX1013195MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ MNH MNI NKB OSH00643169465725
CD HORIZON® Spinal SystemX1013177MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ MNH MNI NKB OSH00643169465909
CD HORIZON® Spinal SystemX1013189MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ MNH MNI NKB OSH00643169465787
CD HORIZON® Spinal SystemX1013186MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ MNH MNI NKB OSH00643169465817
CD HORIZON® Spinal SystemX1013184MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ MNH MNI NKB OSH00643169465831
CD HORIZON® Spinal SystemX1013182MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ MNH MNI NKB OSH00643169465855
CD HORIZON® Spinal SystemX1013190MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ MNH MNI NKB OSH00643169465770
CD HORIZON® Spinal SystemX1013199MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ MNH MNI NKB OSH00643169465688
CD HORIZON® Spinal SystemX1013205MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ MNH MNI NKB OSH00643169468665
Medtronic Reusable InstrumentsX1013178MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ MNH MNI NKB OSH00643169465893
CD HORIZON® Spinal SystemX1013207MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ MNH MNI NKB OSH00643169468689
CD HORIZON® Spinal SystemX1013183MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ MNH MNI NKB OSH00643169465848
CD HORIZON® Spinal SystemX1013196MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ MNH MNI NKB OSH00643169465718
CD HORIZON® Spinal SystemX1013212MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ MNH MNI NKB OSH00643169468733
CD HORIZON® Spinal SystemX1013193MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ MNH MNI NKB OSH00643169465749
CD HORIZON® Spinal SystemX1013197MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ MNH MNI NKB OSH00643169465701
CD HORIZON® Spinal SystemX1013181MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ MNH MNI NKB OSH00643169465862