510(k) Report

Devices descending from K040583

1,161 later devices reach Modification to: CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061592Modification to CD Horizon SystemMedtronic Sofamor Danek, Inc.20060—
+1K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005780—
+1K050981CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005786—
+1K043488Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek20051,128—
+1K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20049874
+1K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004988—
+2K223494CD Horizon Spinal SystemMedtronic202317—
+2K221244CD Horizon™ Spinal SystemMedtronic202220—
+2K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+2K210637CD Horizon™ Spinal SystemMedtronic202134—
+2K202771CD Horizon Spinal SystemMedtronic202021—
+2K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+2K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+2K173126Arisstos™ Spinal SystemIngenium Spine20171—
+2K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+2K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+2K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+2K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014212—
+2K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+2K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+2K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+2K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+2K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+2K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+2K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+2K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+2K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+2K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597—
+2K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+2K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598—
+2K101074Modification to: CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2010225—
+2K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+2K093058TSRH Spinal SystemMedtronic Sofamor Danek, Inc.2009478—
+2K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20096561
+2K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009776—
+2K090390CD Horizon Spinal SystemMedtronic Sofamor Danek2009663—
+2K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+2K081080TSRH Spinal SystemMedtronic Sofamor Danek2008614—
+2K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+2K072317Modification to:TSRH Spinal SystemMedtronic Sofamor Danek USA, Inc.20076254
+2K071033T2 XVBR Spinal SystemMedtronic Sofamor Danek200750—
+2K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek2007821—
+2K063083Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20060—
+2K060615CD Horizon Spinal SystemMedtronic Sofamor Danek200682234
+2K061591Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2006660—
+2K061162Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc.2006131—
+2K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine2006710—
+2K053474CD Horizon Spinal SystemMedtronic Sofamor Danek2006657—
+2K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006778—
+2K052054TSRH Spinal SystemMedtronic Sofamor Danek2005786—
+2K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005870—
+2K050484Basis Spinal SystemMedtronic Sofamor Danek, Inc.20050—
+2K043321Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek20050—
+2K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005880—
+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—
+3K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+3K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+3K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+3K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K253331PressON Spinal Fixation SystemNexus Spine20250—
+3K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+3K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+3K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+3K241258Ingenix Spinal SystemIngenium Spine20240—
+3K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+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—
+3K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+3K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+3K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+3K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+3K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+3K220486Kentrospine PSS Pedicle Screw SystemRivarp Medical Private Limited20220—
+3K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+3K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+3K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+3K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+3K201737Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20211—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+3K210306GII Spinal Fixation SystemColigne AG20210—
+3K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+3K201457Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemAuxein Medical Private Limited/7116420212—
+3K202505GetSet Surgical GoPLF! Posterior Lateral Fusion SystemGetset Surgical, SA20210—
+3K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+3K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+3K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+3K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+3K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+3K180337EUROPA Pedicle Screw SystemMiRus, LLC20196—
+3K182970EUROPA™ Pedicle Screw SystemMiRus, LLC20192—
+3K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+3K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+3K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+3K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+3K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—