510(k) Report

Devices descending from K140449

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+1K151216Everest Spinal SystemK2m, Inc.201511—
+1K141398Pass LP Spinal SystemMedicrea International SA2015101
+2K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+2K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+2K210637CD Horizon™ Spinal SystemMedtronic202134—
+2K173508Everest Spinal SystemK2m20189—
+2K160640PASS XS Spinal SystemMedicrea International SA20160—
+2K161627PASS LP Spinal SystemMedicrea International SA20167—
+2K153413PASS LP Spinal SystemMedicrea International SA20160—
+2K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+3K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+3K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+3K223494CD Horizon Spinal SystemMedtronic202317—
+3K221244CD Horizon™ Spinal SystemMedtronic202220—
+3K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+3K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+3K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+4K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+4K253331PressON Spinal Fixation SystemNexus Spine20250—
+4K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+4K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K252322SIros-X SystemGenesys Spine20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+6K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+6K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+6K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—