510(k) Report

Devices descending from K042453

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+5K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+5K210637CD Horizon™ Spinal SystemMedtronic202134—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K201457Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemAuxein Medical Private Limited/7116420212—
+5K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+5K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+5K202771CD Horizon Spinal SystemMedtronic202021—
+5K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+5K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+5K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+5K193224Daytona® Small Stature Growth Rod Conversion SetSeaSpine Orthopedics Corporation20202—
+5K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+5K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+5K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+5K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+5K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+5K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+5K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+5K183381Navigation Enabled InstrumentsStryker20191—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+5K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K171321K2M Navigation InstrumentsK2m201711
+5K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+5K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+5K170647Connector SystemOrthofix, Inc.201718—
+5K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+5K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+5K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+5K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+5K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+5K161842Overwatch Spine SystemAmendia, Inc.201661
+5K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+5K161627PASS LP Spinal SystemMedicrea International SA20167—
+5K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+5K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+5K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+5K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+5K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+5K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+5K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+5K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+5K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+5K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+5K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+5K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+5K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+5K142360Everest Spinal SystemK2m, Inc.201522—
+5K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+5K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+5K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+5K142499Reline SystemNu Vasive, Incorporated201478—
+5K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014286—
+5K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+5K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+5K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+5K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+5K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+5K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+5K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+5K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+5K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+5K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+5K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+5K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+5K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+5K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+5K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+5K122592Instinct Java SystemZimmer Spine201301
+5K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+5K121728Tiger Spine SystemCorelink, LLC201250—
+5K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+5K121172Reform Pedicle Screw SystemSpinal USA201233—
+5K120838Synthes Matrix SystemSynthes Spine201216—
+5K120564Calypso SystemHogan Lovells US LLP201216—
+5K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+5K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+5K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+5K120928Synthes Matrix SystemSynthes Spine20120—
+5K121020Viper SystemDepuy Spine, Inc.201294—
+5K120696Tiger Spine SystemCorelink, LLC201241—
+5K101971Syntec OS Spinal Fixation SystemSyntec Scientific Corp.20110—
+5K092325Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20093—
+5K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+5K062606CD Horizon Spinal SystemMedtronic Sofamor Danek20062—