510(k) Report

Devices descending from K001066

768 later devices reach CD Horizon Eclipse through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043343Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004595—
+1K030087Spinal Concepts, Inc. Bacfix TI Spinal SystemSpinal Concepts, Inc.20030—
+1K012916Frontier Anterior Scoliosis SystemDepuy Acromed, Inc.2001601—
+2K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+2K071668Orthobiom Spinal SystemParadigm Spine2008582—
+2K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+2K052747Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek2005528—
+2K051674CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005587—
+2K041205Expedium Anterior Spine SystemDepuy Spine, Inc.2004140—
+3K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+3K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+3K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+3K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+3K121630Range Spinal SystemK2m, Inc.2012127—
+3K113666Xia 3 Spinal SystemStryker Spine2012251—
+3K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+3K113529CD Horizon Voyager Spinal SystemMedtronic Sofamor Danek2012316—
+3K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc.20119—
+3K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2010517—
+3K091445CD Horizon Spinal SystemMedtronic Sofamor Danek2010581—
+3K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+3K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc.200810—
+3K063417Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2007576—
+3K063083Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20060—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+4K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—
+4K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+4K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K191726mont blanc & mont blanc MIS Spinal SystemsSpineway SA20190—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+4K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+4K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+4K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+4K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+4K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+4K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K171582NEO Pedicle Screw System™Neo Medical SA20170—
+4K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+4K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+4K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+4K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+4K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+4K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+4K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+4K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+4K150294DPZ Pedicular Fixation SystemOsteomed Implantes, Ltda20150—
+4K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+4K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+4K150417Astra Spine SystemSpinecraft, LLC201521—
+4K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+4K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+4K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515—
+4K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+4K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+4K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+4K142381Xia 3 Spinal SystemStryker Corp.201483—
+4K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K141044M.U.S.T. ExtensionMedacta International201416—
+4K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+4K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+4K132878M.U.S.T. ExtensionMedacta International201328—
+4K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+4K132603Apex Spine SystemSpinecraft, LLC201325—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K132303Implanet Spine SystemImplanet, S.A.201315—
+4K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+4K131784Range Spinal SystemK2m, Inc.201334—
+4K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+4K130438Axle Interspinous Fusion SystemX-Spine Systems, Inc.2013181
+4K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+4K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+4K130655Response Spine SystemOrthoPediatrics Corp.201317—
+4K122877Range Spinal System, Small StatureK2m, Inc.201334—
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+4K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+4K120838Synthes Matrix SystemSynthes Spine201216—
+4K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+4K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+4K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+4K120928Synthes Matrix SystemSynthes Spine20120—