510(k) Report

Devices descending from K043343

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+4K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+4K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+4K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+4K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+4K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K141850Flospine Pedicle Screw SystemFlospine20140—
+4K142381Xia 3 Spinal SystemStryker Corp.201483—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+4K131784Range Spinal SystemK2m, Inc.201334—
+4K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+4K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+4K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013100—
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+4K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+4K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+4K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+4K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+4K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+4K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+5K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+5K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K253249TriALTIS™ Spine SystemMedos International SARL20251—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+5K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+5K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+5K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+5K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+5K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+5K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+5K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+5K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+5K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+5K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+5K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+5K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+5K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+5K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+5K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+5K203816DeGen Navigated InstrumentationDegen Medical20211—
+5K210472SPINEART Navigation Instrument SystemSpineart20215—
+5K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+5K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+5K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+5K202771CD Horizon Spinal SystemMedtronic202021—
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+5K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+5K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+5K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+5K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+5K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—