510(k) Report

Devices descending from K042453

898 later devices reach Modification to Equation Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+1K072022Valeo Pedicle Screw Spinal SystemAmedica Corp.2007100—
+1K042962Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004897—
+2K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+2K151977icotec Pedicle SystemIcotec AG201630—
+2K141044M.U.S.T. ExtensionMedacta International201416—
+2K132878M.U.S.T. ExtensionMedacta International201328—
+2K122877Range Spinal System, Small StatureK2m, Inc.201334—
+2K121630Range Spinal SystemK2m, Inc.2012127—
+2K121764CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201245—
+2K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+2K120491DSS Stabilization System-RigidParadigm Spine, LLC20120—
+2K113625DSS Stabilization SystemParadigm Spine, LLC20121—
+2K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+2K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek2007821—
+2K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005870—
+3K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+3K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+3K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+3K222789VADER® Pedicle System, G21 CementIcotec AG202352
+3K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+3K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+3K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+3K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+3K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+3K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+3K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+3K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K133904CD Horizon Spinal System Growth Rod SetMedtronic Sofamor Danek USA201443—
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K123552Instinct Java SystemZimmer Spine201301
+3K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+3K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+3K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+3K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20096561
+3K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+3K083825Eoi Spinal SystemExpanding Orthopedics, Inc.20090—
+3K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+3K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+3K082236CD Horizon Spinal SystemMedtronic Sofamor Danek2008779—
+3K080767Conquest Spinal SystemLife Spine200821—
+3K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+3K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+3K061915CD Horizon Spinal SystemMedtronic Sofamor Danek200654—
+3K052747Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek2005528—
+3K052609Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek200554—
+3K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005780—
+3K051674CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005587—
+4K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K232628VADER® Pedicle SystemIcotec AG20241—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+4K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+4K221244CD Horizon™ Spinal SystemMedtronic202220—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+4K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+4K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+4K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+4K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+4K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+4K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+4K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+4K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+4K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—