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

Clearance record K142591

CD HORIZON Spinal System · Medtronic Sofamor Danek USA, Inc. · decided 2014-12-01 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
CD HORIZON® Spinal System45410006545MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169428614
CD HORIZON ESSENCE™ Spinal System45440007540MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00763000794521
CD HORIZON® Spinal System45410006535MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00763000794446
CD HORIZON® Spinal System45410005550MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00763000794439
CD HORIZON ESSENCE™ Spinal System45440007540MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169428676
CD HORIZON ESSENCE™ Spinal System45440004520MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00763000794682
CD HORIZON ESSENCE™ Spinal System45440005550MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169428751
CD HORIZON ESSENCE™ Spinal System45440004520MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169428836
CD HORIZON ESSENTIALS™ Spinal System45340007545MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169428959
CD HORIZON ESSENTIALS™ Spinal System4530020MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169428928
CD HORIZON ESSENCE™ Spinal System45440006540MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00763000794576
CD HORIZON ESSENCE™ Spinal System45440008560MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00763000794491
CD HORIZON ESSENCE™ Spinal System45440005540MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169428775
CD HORIZON® Spinal System45410006540MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169428607
CD HORIZON ESSENCE™ Spinal System4540020MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00763000802134
CD HORIZON ESSENCE™ Spinal System45410005540MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169428560
CD HORIZON ESSENCE™ Spinal System45440007550MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00763000794507
CD HORIZON® Spinal System45410006545MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00763000794460
CD HORIZON® Spinal System45410006550MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00763000794477
CD HORIZON ESSENTIALS™ Spinal System45340006540MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169429062
CD HORIZON® Spinal System45410006540MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00763000794453
CD HORIZON ESSENCE™ Spinal System45440008560MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169428645
CD HORIZON ESSENCE™ Spinal System45440005540MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00763000794620
CD HORIZON ESSENCE™ Spinal System45440004535MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00763000794675
CD HORIZON ESSENCE™ Spinal System45440004540MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00763000794668