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

Clearance record K182121

CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition · Medtronic Sofamor Danek USA, Inc. · decided 2018-11-02 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
CD HORIZON® Spinal SystemRBT052102MEDTRONIC SOFAMOR DANEK, INC.OLO00763000082192
CD HORIZON® Spinal SystemRBT012202MEDTRONIC SOFAMOR DANEK, INC.OLO00763000082086
CD HORIZON® Spinal SystemRBT034202MEDTRONIC SOFAMOR DANEK, INC.OLO00763000140427
CD HORIZON® Spinal SystemRBT052202MEDTRONIC SOFAMOR DANEK, INC.OLO00763000082154
CD HORIZON® Spinal SystemRBT024102MEDTRONIC SOFAMOR DANEK, INC.OLO00763000140373
CD HORIZON® Spinal SystemRBT023202MEDTRONIC SOFAMOR DANEK, INC.OLO00763000011277
CD HORIZON® Spinal SystemRBT011209MEDTRONIC SOFAMOR DANEK, INC.OLO00763000023676
CD HORIZON® Spinal SystemRBT011210MEDTRONIC SOFAMOR DANEK, INC.OLO00763000082246
CD HORIZON® Spinal SystemRBT011206MEDTRONIC SOFAMOR DANEK, INC.OLO00763000023645
CD HORIZON® Spinal SystemRBT024502MEDTRONIC SOFAMOR DANEK, INC.OLO00763000374082
CD HORIZON® Spinal SystemRBT011204MEDTRONIC SOFAMOR DANEK, INC.OLO00763000023621
CD HORIZON® Spinal SystemRBT023201MEDTRONIC SOFAMOR DANEK, INC.OLO00763000011260
CD HORIZON® Spinal SystemRBT090000MEDTRONIC SOFAMOR DANEK, INC.OLO00763000082376
CD HORIZON® Spinal SystemRBT051211MEDTRONIC SOFAMOR DANEK, INC.OLO00763000082314
CD HORIZON® Spinal SystemRBT023101MEDTRONIC SOFAMOR DANEK, INC.OLO00763000011246
CD HORIZON® Spinal SystemRBT051206MEDTRONIC SOFAMOR DANEK, INC.OLO00763000023744
CD HORIZON® Spinal SystemRBT090004MEDTRONIC SOFAMOR DANEK, INC.OLO00763000082383
CD HORIZON® Spinal SystemRBT033302MEDTRONIC SOFAMOR DANEK, INC.OLO00763000011284
CD HORIZON® Spinal SystemRBT034502MEDTRONIC SOFAMOR DANEK, INC.OLO00763000374105
CD HORIZON® Spinal SystemRBT011009MEDTRONIC SOFAMOR DANEK, INC.OLO00763000023737
CD HORIZON® Spinal SystemRBT024101MEDTRONIC SOFAMOR DANEK, INC.OLO00763000140380
CD HORIZON® Spinal SystemRBT011008MEDTRONIC SOFAMOR DANEK, INC.OLO00763000023720
CD HORIZON® Spinal SystemRBT023301MEDTRONIC SOFAMOR DANEK, INC.OLO00763000011239
CD HORIZON® Spinal SystemRBT062401MEDTRONIC SOFAMOR DANEK, INC.OLO00763000306809
CD HORIZON® Spinal SystemRBT090012MEDTRONIC SOFAMOR DANEK, INC.OLO00763000159603