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

Clearance record K201362

CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement · Medtronic · decided 2020-08-19 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
CD HORIZON® SOLERA® Spinal System651703060MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ NKB00763000211646
CD HORIZON® SOLERA® VOYAGER™ Spinal System55851004525MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ NKB00763000211240
CD HORIZON® Fenestrated Screw Set55750028575MEDTRONIC SOFAMOR DANEK, INC.NDN NKB00763000148553
CD HORIZON® Fenestrated Screw Set55851026565MEDTRONIC SOFAMOR DANEK, INC.NDN NKB00763000145705
CD HORIZON® Fenestrated Screw Set55851026575MEDTRONIC SOFAMOR DANEK, INC.NDN NKB00763000145729
CD HORIZON® Fenestrated Screw Set55751025065MEDTRONIC SOFAMOR DANEK, INC.NDN NKB00763000150501
CD HORIZON® Fenestrated Screw Set55851027560MEDTRONIC SOFAMOR DANEK, INC.NDN NKB00763000146030
CD HORIZON® Fenestrated Screw Set55851025055MEDTRONIC SOFAMOR DANEK, INC.NDN NKB00763000143640
CD HORIZON® Fenestrated Screw Set55750029575MEDTRONIC SOFAMOR DANEK, INC.NDN NKB00763000149949
CD HORIZON® Fenestrated Screw Set55851025030MEDTRONIC SOFAMOR DANEK, INC.NDN NKB00763000143596
CD HORIZON® SOLERA® VOYAGER™ Spinal System6550038MEDTRONIC SOFAMOR DANEK, INC.HBE00763000216719
CD HORIZON® Fenestrated Screw Set55750024560MEDTRONIC SOFAMOR DANEK, INC.NDN NKB00763000149376
CD HORIZON® Fenestrated Screw Set55750026535MEDTRONIC SOFAMOR DANEK, INC.NDN NKB00763000148812
CD HORIZON® Fenestrated Screw Set55851025535MEDTRONIC SOFAMOR DANEK, INC.NDN NKB00763000143732
CD HORIZON® Fenestrated Screw Set55851024560MEDTRONIC SOFAMOR DANEK, INC.NDN NKB00763000143541
CD HORIZON® SOLERA® VOYAGER™ Spinal System6541101MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ NKB00763000211196
CD HORIZON® Fenestrated Screw Set55750024550MEDTRONIC SOFAMOR DANEK, INC.NDN NKB00763000149352
CD HORIZON® Fenestrated Screw Set55851027545MEDTRONIC SOFAMOR DANEK, INC.NDN NKB00763000146009
CD HORIZON® Fenestrated Screw Set55851025070MEDTRONIC SOFAMOR DANEK, INC.NDN NKB00763000143671
CD HORIZON® SOLERA® VOYAGER™ Spinal System6541102MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ NKB20763000211206
CD HORIZON® SOLERA® Spinal System654700060MEDTRONIC SOFAMOR DANEK, INC.HWE KWP KWQ NKB00763000213589
CD HORIZON® Fenestrated Screw Set55750024565MEDTRONIC SOFAMOR DANEK, INC.NDN NKB00763000149383
CD HORIZON® Fenestrated Screw Set55851025565MEDTRONIC SOFAMOR DANEK, INC.NDN NKB00763000143794
CD HORIZON® Fenestrated Screw Set55751025075MEDTRONIC SOFAMOR DANEK, INC.NDN NKB00763000150525
CD HORIZON® Fenestrated Screw Set55851024570MEDTRONIC SOFAMOR DANEK, INC.NDN NKB00763000143565