510(k) Report

Devices descending from K041030

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+1K082236CD Horizon Spinal SystemMedtronic Sofamor Danek2008779—
+1K060203Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek20060—
+1K052144TSRH Spinal SystemMedtronic Sofamor Danek20056651
+1K042210MSD Silo Spinal SystemMedtronic Sofamor Danek20046661
+2K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+2K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+2K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+2K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+2K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+2K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+2K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+2K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+2K101074Modification to: CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2010225—
+2K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20096561
+2K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009776—
+2K090390CD Horizon Spinal SystemMedtronic Sofamor Danek2009663—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+3K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+3K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+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—
+3K221244CD Horizon™ Spinal SystemMedtronic202220—
+3K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+3K210637CD Horizon™ Spinal SystemMedtronic202134—
+3K201457Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemAuxein Medical Private Limited/7116420212—
+3K202505GetSet Surgical GoPLF! Posterior Lateral Fusion SystemGetset Surgical, SA20210—
+3K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+3K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+3K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+3K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201858—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+3K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+3K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+3K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+3K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+3K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+3K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+3K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+3K142499Reline SystemNu Vasive, Incorporated201478—
+3K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+3K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014273—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K140529Everest Spinal SystemK2m, LLC201431—
+3K140449CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201459—
+3K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+3K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+3K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+3K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+3K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+3K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+3K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+3K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20115961
+3K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011597—
+3K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011597—
+3K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+3K101971Syntec OS Spinal Fixation SystemSyntec Scientific Corp.20110—
+3K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598—
+3K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+3K092325Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20093—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+4K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+4K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+4K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+4K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+4K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+4K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+4K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+4K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+4K223494CD Horizon Spinal SystemMedtronic202317—
+4K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+4K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+4K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+4K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+4K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+4K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+4K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—