510(k) Report

Devices descending from K013962

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+6K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+6K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K220486Kentrospine PSS Pedicle Screw SystemRivarp Medical Private Limited20220—
+6K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+6K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+6K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+6K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+6K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+6K210637CD Horizon™ Spinal SystemMedtronic202134—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K201457Auxein Brand Vertaux 5.5 mm Pedicle Screw SystemAuxein Medical Private Limited/7116420212—
+6K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+6K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+6K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K202771CD Horizon Spinal SystemMedtronic202021—
+6K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+6K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+6K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+6K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+6K193224Daytona® Small Stature Growth Rod Conversion SetSeaSpine Orthopedics Corporation20202—
+6K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+6K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+6K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+6K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+6K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+6K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+6K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+6K183381Navigation Enabled InstrumentsStryker20191—
+6K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+6K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+6K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+6K172115Navigated Instrument SystemOrthofix, Inc.20184—
+6K171321K2M Navigation InstrumentsK2m201711
+6K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+6K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+6K170647Connector SystemOrthofix, Inc.201718—
+6K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+6K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+6K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+6K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+6K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+6K161842Overwatch Spine SystemAmendia, Inc.201661
+6K162494CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201627—
+6K161627PASS LP Spinal SystemMedicrea International SA20167—
+6K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+6K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+6K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+6K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+6K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+6K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+6K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+6K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+6K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+6K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+6K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+6K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+6K143684NuVasive Reline SystemNu Vasive, Incorporated201577—
+6K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+6K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141—
+6K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+6K142499Reline SystemNu Vasive, Incorporated201478—
+6K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014286—
+6K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014210—
+6K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+6K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+6K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+6K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+6K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+6K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+6K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+6K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+6K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+6K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+6K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+6K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+6K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+6K123623Illico Mis Posterior Fixation SystemAlphatec Spine, Inc.201321
+6K122592Instinct Java SystemZimmer Spine201301
+6K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+6K121728Tiger Spine SystemCorelink, LLC201250—
+6K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+6K121172Reform Pedicle Screw SystemSpinal USA201233—
+6K120838Synthes Matrix SystemSynthes Spine201216—
+6K120564Calypso SystemHogan Lovells US LLP201216—
+6K121016Range Spinal System (Mesa and Denali)K2m, Inc.201238—
+6K121342Xia 4.5 Spinal SystemStryker Corp.201288—