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

Clearance record K233951

CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) · Medtronic Sofamor Danek USA, Inc. · decided 2024-03-27 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
CD Horizon™ ModuLeX™ Spinal System55901619500MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000858568
CD Horizon™ ModuLeX™ Spinal System55901610210MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000858414
CD Horizon™ ModuLeX™ Spinal System55901600390MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000859084
CD Horizon™ ModuLeX™ Spinal System55901617580MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000858506
CD Horizon™ ModuLeX™ Spinal System55901617570MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000858490
CD Horizon™ ModuLeX™ Spinal System55901600300MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000859053
CD Horizon™ ModuLeX™ Spinal System55900610190MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000859251
CD Horizon™ ModuLeX™ Spinal System55901619510MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000858575
CD Horizon™ ModuLeX™ Spinal System55901610180MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000858384
CD Horizon™ ModuLeX™ Spinal System55900610100MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000859213
CD Horizon™ ModuLeX™ Spinal System55900618500MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000859305
CD Horizon™ ModuLeX™ Spinal System55901610170MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000858377
CD Horizon™ ModuLeX™ Spinal System55901618590MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000858551
CD Horizon™ ModuLeX™ Spinal System55900600110MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000861391
CD Horizon™ ModuLeX™ Spinal System55901618570MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000858537
CD Horizon™ ModuLeX™ Spinal System55900617570MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000859275
CD Horizon™ ModuLeX™ Spinal System55900608580MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000861490
CD Horizon™ ModuLeX™ Spinal System55901619590MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000858605
CD Horizon™ ModuLeX™ Spinal System55900607580MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000861452
CD Horizon™ ModuLeX™ Spinal System559200082MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000859398
CD Horizon™ ModuLeX™ Spinal System55900618570MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000859312
CD Horizon™ ModuLeX™ Spinal System55900617550MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000891459
CD Horizon™ ModuLeX™ Spinal System55901610110MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000858360
CD Horizon™ ModuLeX™ Spinal System55900608510MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000891367
CD Horizon™ ModuLeX™ Spinal System55901600380MEDTRONIC SOFAMOR DANEK, INC.KWP KWQ NKB00763000859077