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

Clearance record K191066

CD Horizon™ Astute™ Spinal System · Medtronic Sofamor Danek USA, Inc. · decided 2019-10-03 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
CD Horizon™ Astute™ Spinal System1608451090MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB NQP00763000313043
CD Horizon™ Astute™ Spinal System1608451025MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB NQP00763000312916
CD Horizon™ Astute™ Spinal System5530620MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB NQP00763000313333
CD Horizon™ Astute™ Spinal System1608451110MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB NQP00763000313081
CD HORIZON ASTUTE SPINAL SYSTEM1608451060MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB NQP00643169281172
CD Horizon™ Astute™ Spinal System1608451105MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB NQP00763000313074
CD Horizon™ Astute™ Spinal System1608451100MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB NQP00763000313067
CD Horizon™ Astute™ Spinal System1608451075MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB NQP00763000313012
CD HORIZON® ASTUTE™ SPINAL SYSTEM1608451070MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB NQP00643169281165
CD Horizon™ Astute™ Spinal System1608451065MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB NQP00763000312992
CD Horizon™ Astute™ Spinal System1608451050MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB NQP00763000312961
CD Horizon™ Astute™ Spinal System1608451080MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB NQP00763000313029
CD Horizon™ Astute™ Spinal System1608451095MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB NQP00763000313050
CD Horizon™ Astute™ Spinal System1608451120MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB NQP00763000313104
CD Horizon™ Astute™ Spinal System1608451130MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB NQP00763000313128
CD Horizon™ Astute™ Spinal System1608451125MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB NQP00763000313111
CD Horizon™ Astute™ Spinal System1608451060MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB NQP00763000312985
CD Horizon™ Astute™ Spinal System1608451085MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB NQP00763000313036
CD HORIZON® ASTUTE™ SPINAL SYSTEM1608451035MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB NQP00643169281110
CD HORIZON® ASTUTE™ SPINAL SYSTEM1608451090MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB NQP00643169281264
CD Horizon™ Astute™ Spinal System1608451040MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB NQP00763000312947
CD Horizon™ Astute™ Spinal System1608451070MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB NQP00763000313005
CD Horizon™ Astute™ Spinal System1608451035MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB NQP00763000312930
CD Horizon™ Astute™ Spinal System1608451045MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB NQP00763000312954
CD Horizon™ Astute™ Spinal System1608451115MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB NQP00763000313098