510(k) Report

Devices descending from K210637

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+1K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+1K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+1K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+1K223494CD Horizon Spinal SystemMedtronic202317—
+1K221244CD Horizon™ Spinal SystemMedtronic202220—
+1K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+2K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+2K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+2K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+2K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+2K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+2K253331PressON Spinal Fixation SystemNexus Spine20250—
+2K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+2K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+2K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+2K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+3K252322SIros-X SystemGenesys Spine20250—
+3K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+3K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+4K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+4K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+4K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—