510(k) Report

Devices descending from K013962

900 later devices reach Equation Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+1K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+1K060081Basis Spinal SystemMedtronic Sofamor Danek20060—
+1K042453Modification to Equation Fixation SystemMedtronic Sofamor Danek, Inc.2004898—
+2K240392JAZZ Spinal SystemImplanet20241—
+2K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+2K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+2K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+2K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+2K072022Valeo Pedicle Screw Spinal SystemAmedica Corp.2007100—
+2K042962Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004897—
+3K252437JAZZ Spinal SystemImplanet20250—
+3K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+3K151977icotec Pedicle SystemIcotec AG201630—
+3K141044M.U.S.T. ExtensionMedacta International201416—
+3K132878M.U.S.T. ExtensionMedacta International201328—
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+3K121630Range Spinal SystemK2m, Inc.2012127—
+3K121764CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201245—
+3K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+3K120491DSS Stabilization System-RigidParadigm Spine, LLC20120—
+3K113625DSS Stabilization SystemParadigm Spine, LLC20121—
+3K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+3K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek2007821—
+3K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005870—
+4K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+4K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K222789VADER® Pedicle System, G21 CementIcotec AG202352
+4K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+4K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+4K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+4K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+4K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+4K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+4K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+4K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+4K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+4K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+4K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K133904CD Horizon Spinal System Growth Rod SetMedtronic Sofamor Danek USA201443—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K131784Range Spinal SystemK2m, Inc.201334—
+4K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K123552Instinct Java SystemZimmer Spine201301
+4K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+4K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+4K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+4K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20096561
+4K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+4K083825Eoi Spinal SystemExpanding Orthopedics, Inc.20090—
+4K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+4K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+4K082236CD Horizon Spinal SystemMedtronic Sofamor Danek2008779—
+4K080767Conquest Spinal SystemLife Spine200821—
+4K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+4K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+4K061915CD Horizon Spinal SystemMedtronic Sofamor Danek200654—
+4K052747Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek2005528—
+4K052609Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek200554—
+4K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005780—
+4K051674CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005587—
+5K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+5K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+5K232628VADER® Pedicle SystemIcotec AG20241—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+5K221244CD Horizon™ Spinal SystemMedtronic202220—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+5K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+5K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+5K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+5K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+5K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—