510(k) Report

Devices descending from K083026

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+5K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+5K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+5K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+5K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+5K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+5K200316UNiD IB3D ALIFMedicrea International SA20200—
+5K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+5K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+5K201585Monterey AL Interbody SystemStryker Corporation202044
+5K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+5K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+5K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+5K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+5K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+5K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+5K192993Scarlet AL-TSpineart20201—
+5K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+5K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+5K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+5K193174Keos Lumbar IBFDKeos20190—
+5K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+5K1803473d CageFims Co., Ltd.20190—
+5K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+5K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+5K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+5K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+5K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+5K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+5K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+5K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+5K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+5K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+5K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+5K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+5K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+5K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+5K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+5K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+5K181397DualXInnovasive, Inc.201815—
+5K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+5K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+5K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+5K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+5K180695FBC 921 (Alif)Fbc Device Aps20180—
+5K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+5K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+5K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+5K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+5K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+5K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+5K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+5K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+5K170235Lucent®Spinal Elements, Inc.2017107—
+5K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+5K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+5K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+5K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+5K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+5K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+5K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+5K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+5K163180Hubble IIOrbbo Surgical, LLC20160—
+5K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+5K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+5K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+5K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+5K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+5K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+5K153400ProLift Expandable SystemLife Spine, Inc.201672—
+5K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+5K152651AccuLIF TL and PL CageStryker Corporation201530—
+5K152304Tritanium PL CageStryker20154481
+5K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+5K141135Juliet LLSpineart2014146—
+5K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+5K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+5K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+5K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+5K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+5K130194Acculif XL CageCoalign Innovations, Inc.20131—
+6K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—