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

Clearance record K143569

CD HORIZON Spinal System · Medtronic Sofamor Danek USA, Inc. · decided 2015-02-12 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
CD HORIZON® SOLERA® Spinal System5444370MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169206779
CD HORIZON® SOLERA® Spinal System5464320MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169207011
CD HORIZON® SOLERA® Spinal System5564325MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169207127
CD HORIZON® SOLERA® Spinal System5444325MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169206687
CD HORIZON® SOLERA® Spinal System5444320MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169206670
CD HORIZON® SOLERA® Spinal System5564320MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169207110
CD HORIZON® SOLERA® Spinal System5464325MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169207004
(unnamed)1850096MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169072640
CD HORIZON® SOLERA® Spinal System5564330MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169207134
CD HORIZON® SOLERA® Spinal SystemX0715007MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169657267
CD HORIZON® SOLERA® Spinal System5564370MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169207219
CD HORIZON® SOLERA® Spinal System5554370MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169206977
(unnamed)7069093MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169352346
CD HORIZON® SOLERA® Spinal System5464370MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169207103
CD HORIZON® SOLERA® Spinal System5464335MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169207035
(unnamed)7069094MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169357792
CD HORIZON® SOLERA® Spinal System5444335MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169206700
CD HORIZON® SOLERA® Spinal SystemX0715005MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169657243
CD HORIZON® Spinal System7069098MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169542853
CD HORIZON® SOLERA® Spinal SystemX0715003MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169657229
CD HORIZON® SOLERA® Spinal System5564335MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169207141