510(k) Report

Devices descending from K042025

987 later devices reach Modification to CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223494CD Horizon Spinal SystemMedtronic202317—
+1K221244CD Horizon™ Spinal SystemMedtronic202220—
+1K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+1K210637CD Horizon™ Spinal SystemMedtronic202134—
+1K202771CD Horizon Spinal SystemMedtronic202021—
+1K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+1K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+1K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+1K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+1K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+1K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014212—
+1K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+1K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+1K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+1K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+1K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+1K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+1K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+1K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+1K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+1K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597—
+1K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598—
+1K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20096561
+1K081080TSRH Spinal SystemMedtronic Sofamor Danek2008614—
+1K072317Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc.20076254
+1K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek2007821—
+1K063083Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20060—
+1K060615CD Horizon Spinal SystemMedtronic Sofamor Danek200682234
+1K061591Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2006660—
+1K053474CD Horizon Spinal SystemMedtronic Sofamor Danek2006657—
+1K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006778—
+1K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005780—
+1K052054TSRH Spinal SystemMedtronic Sofamor Danek2005786—
+1K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005870—
+1K050484Basis Spinal SystemMedtronic Sofamor Danek, Inc.20050—
+1K043321Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek20050—
+1K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005880—
+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—
+2K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+2K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+2K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+2K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+2K253331PressON Spinal Fixation SystemNexus Spine20250—
+2K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+2K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+2K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+2K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+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—
+2K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+2K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+2K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+2K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+2K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+2K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+2K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+2K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+2K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+2K201737Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20211—
+2K211323ASTRA Spine SystemSpinecraft, LLC202112—
+2K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+2K210306GII Spinal Fixation SystemColigne AG20210—
+2K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+2K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+2K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+2K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+2K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+2K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+2K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+2K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+2K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+2K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+2K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+2K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+2K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+2K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+2K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl2016106—
+2K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+2K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+2K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+2K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+2K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+2K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+2K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+2K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+2K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+2K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+2K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+2K142531F1-Modular Pedicle Screw SystemDegen Medical20152—
+2K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+2K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+2K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+2K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+2K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014286—
+2K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014273—
+2K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+2K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502