510(k) Report

Devices descending from K032033

1,106 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K101971Syntec OS Spinal Fixation SystemSyntec Scientific Corp.20110—
+3K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+3K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company2010218—
+3K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+3K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+3K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010598—
+3K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+3K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+3K100737Modification to: Trio+Spinal Fixation SystemStryker Spine201086—
+3K092325Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20093—
+3K092631Mantis Redux Spinal SystemStryker Spine2009110—
+3K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+3K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine2009169—
+3K083393Xia 3 Spinal SystemStryker Spine20092921
+3K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+3K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+3K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine2008200—
+3K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+3K072605Malibu Spinal SystemSeaspine, Inc.200767—
+3K072426Atlas Spine Pedicle Screw SystemAtlas Spine, LLC200751
+3K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+3K063417Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2007576—
+3K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+3K063428Xia Stainless Steel Spinal SystemStryker Spine2006204—
+3K063083Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20060—
+3K053474CD Horizon Spinal SystemMedtronic Sofamor Danek2006657—
+3K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006778—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+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—
+4K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+4K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+4K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K252322SIros-X SystemGenesys Spine20250—
+4K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+4K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+4K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+4K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+4K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+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—
+4K233300POWEReam 1/4 DriveStryker Instruments20231—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+4K231658VEOS Spinal Fixation SystemSpineway20230—
+4K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+4K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+4K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+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—
+4K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+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—
+4K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+4K223273ASTRA Spine SystemSpinecraft, LLC20228—
+4K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+4K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+4K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+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—
+4K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+4K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+4K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+4K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+4K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+4K211323ASTRA Spine SystemSpinecraft, LLC202112—
+4K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+4K210637CD Horizon™ Spinal SystemMedtronic202134—
+4K210549ARx Spinal SystemLife Spine, Inc.20211—
+4K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+4K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+4K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—