510(k) Report

Devices descending from K083026

1,042 later devices reach Clydesdale Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K202032Idys LLIF 3DTiClariance, Sas20210—
+4K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+4K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+4K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+4K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+4K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+4K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+4K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+4K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+4K200312Tryptik TiSpineart20202—
+4K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+4K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+4K192906Mecta-C Stand AloneMedacta International S.A.20201—
+4K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+4K191796Neo Cage SystemNeo Medical SA20190—
+4K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+4K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+4K191134IB3D AlifMedicrea International SA20191—
+4K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+4K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+4K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+4K191263Idys ALIF TiVacClariance, Sas20190—
+4K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+4K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+4K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+4K181048Neo Cage System TMNeo Medical SA20191—
+4K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+4K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+4K181899Roccia® PlifSilony Medical GmbH20180—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+4K182470Plateau Spacer SystemLife Spine20180—
+4K181963ostaPek Interbody Fusion CagesColigne AG20181—
+4K181818Scarlet AL-TSpineart201864—
+4K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+4K181203Juliet TiSpineart20181—
+4K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+4K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+4K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+4K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+4K172115Navigated Instrument SystemOrthofix, Inc.20184—
+4K172816TiGer Shark™ SystemChoicespine, LP201859—
+4K173702Juliet Ti LLSpineart20182—
+4K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+4K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+4K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+4K163595IMPIX 3D Print CagesMedicrea International SA2017282
+4K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+4K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+4K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+4K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+4K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+4K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+4K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+4K162921Navigated Instrument SystemOrthofix, Inc.20175—
+4K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+4K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+4K161379ELSA SpacersGlobus Medical, Inc.2016155—
+4K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+4K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+4K160631Keos Lumbar IBFDKeos20161—
+4K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+4K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+4K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+4K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+4K150847Foundation Interbody DevicesCorelink, LLC201529—
+4K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+4K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+4K142744Mecta-C TiPEEKMedacta International201512—
+4K143616AccuLIF TL and PL CageStryker Corporation20154694
+4K141896Coroent SystemNu Vasive, Incorporated2014480—
+4K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+4K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+4K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+4K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+4K131276Lateral SynfixSynthes (USA) Products, LLC2014146—
+4K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+4K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+5K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+5K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+5K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+5K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+5K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K253331PressON Spinal Fixation SystemNexus Spine20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+5K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—