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

Clearance record K162379

CD HORIZON® Spinal System · Medtronic Sofamor Danek USA, Inc. · decided 2016-11-16 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
CD HORIZON® SOLERA® Spinal System55720005555MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169761629
CD HORIZON® SOLERA® Spinal System55720006535MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169761919
CD HORIZON® SOLERA® Spinal System55720007555MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169761995
CD HORIZON® SOLERA® Spinal System55720005530MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169761865
CD HORIZON® SOLERA® Spinal System55720008545MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169763104
Medtronic Transportation/Sterilization Cassette5332021MEDTRONIC SOFAMOR DANEK, INC.KCT00643169792005
CD HORIZON® SOLERA® Spinal System55720007540MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169761964
Medtronic Transportation/Sterilization Cassette5332022MEDTRONIC SOFAMOR DANEK, INC.KCT00643169792012
Medtronic Transportation/Sterilization Cassette5332019MEDTRONIC SOFAMOR DANEK, INC.KCT00643169791985
CD HORIZON® SOLERA® Spinal System55720005545MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169761896
CD HORIZON® SOLERA® Spinal System55720008540MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169763098
CD HORIZON® SOLERA® Spinal System55720007545MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169761971
Medtronic Transportation/Sterilization Cassette5332018MEDTRONIC SOFAMOR DANEK, INC.KCT00643169791978
Medtronic Transportation/Sterilization Cassette5332023MEDTRONIC SOFAMOR DANEK, INC.KCT00643169792029
Medtronic Transportation/Sterilization Cassette5332020MEDTRONIC SOFAMOR DANEK, INC.KCT00643169791992
CD HORIZON® SOLERA® Spinal System55720006555MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169761957
CD HORIZON® SOLERA® Spinal System55720006550MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169761940
CD HORIZON® SOLERA® Spinal System55720007550MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169761988
CD HORIZON® SOLERA® Spinal System55720005540MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169761889
CD HORIZON® SOLERA® Spinal System55720006540MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169761926
CD HORIZON® SOLERA® Spinal System55720005535MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169761872
CD HORIZON® SOLERA® Spinal System55720008555MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169762015
CD HORIZON® SOLERA® Spinal System55720008550MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169762008
CD HORIZON® SOLERA® Spinal System55720006530MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169761902
CD HORIZON® SOLERA® Spinal System55720005550MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ MNH MNI NKB OSH00643169761612