510(k) Report

Devices descending from K182121

41 later devices reach CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+1K231184CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20230—
+1K211596CD Horizon Spinal SystemMedtronic20213—
+1K210637CD Horizon™ Spinal SystemMedtronic202134—
+1K203291CD Horizon Spinal System InstrumentsMedtronic Sofamor Danek USA, Inc.202035—
+2K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+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—
+2K223494CD Horizon Spinal SystemMedtronic202317—
+2K221244CD Horizon™ Spinal SystemMedtronic202220—
+2K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+2K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+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—
+3K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+3K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+3K253331PressON Spinal Fixation SystemNexus Spine20250—
+3K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+3K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+3K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+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—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+5K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+5K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—