510(k) Report

Devices descending from K150178

25 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221244CD Horizon™ Spinal SystemMedtronic202220—
+1K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+1K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+2K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+2K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+2K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+2K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+2K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+2K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+2K223494CD Horizon Spinal SystemMedtronic202317—
+2K173126Arisstos™ Spinal SystemIngenium Spine20171—
+3K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+3K253331PressON Spinal Fixation SystemNexus Spine20250—
+3K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+3K241258Ingenix Spinal SystemIngenium Spine20240—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K252322SIros-X SystemGenesys Spine20250—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—