510(k) Report

Devices descending from K020709

1,146 later devices reach Modification to CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K062698Trio + Spinal SystemStryker Spine2006882
+2K053474CD Horizon Spinal SystemMedtronic Sofamor Danek2006657—
+2K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006778—
+2K052761Modification to: Xia 4.5 Spinal SystemStryker Spine2005735—
+2K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005780—
+2K052054TSRH Spinal SystemMedtronic Sofamor Danek2005786—
+2K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005870—
+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—
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K253331PressON Spinal Fixation SystemNexus Spine20250—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+3K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+3K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+3K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+3K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+3K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+3K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K233300POWEReam 1/4 DriveStryker Instruments20231—
+3K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+3K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—
+3K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+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—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+3K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+3K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+3K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+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—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+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—
+3K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+3K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+3K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+3K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+3K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+3K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+3K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+3K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+3K190376PASS LP Spinal SystemMedicrea International SA201915
+3K180337EUROPA Pedicle Screw SystemMiRus, LLC20196—
+3K182970EUROPA™ Pedicle Screw SystemMiRus, LLC20192—
+3K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+3K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+3K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+3K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+3K180376K2M Patient Specific RodsK2m, Inc.20182—
+3K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+3K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+3K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+3K173126Arisstos™ Spinal SystemIngenium Spine20171—
+3K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+3K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+3K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+3K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+3K171838TiLock2 Spinal SystemGenesys Spine20174—
+3K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+3K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+3K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+3K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+3K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+3K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+3K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+3K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—