510(k) Report

Devices descending from K100175

1,008 later devices reach Clydesdale Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+5K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+5K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+5K220610SOLO-LAurora Spine, Inc.20220—
+5K221244CD Horizon™ Spinal SystemMedtronic202220—
+5K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+5K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+5K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+5K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+5K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+5K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+5K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+5K212562Idys-C ZP 3DTiClariance, SA20211—
+5K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+5K211740DualXAmplify Surgical, Inc.20211—
+5K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+5K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+5K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+5K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+5K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+5K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+5K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+5K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+5K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+5K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+5K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+5K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+5K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+5K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+5K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+5K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+5K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+5K200316UNiD IB3D ALIFMedicrea International SA20200—
+5K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+5K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+5K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+5K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+5K201087CORBEL SpacersGlobus Medical, Inc.202036—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+5K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+5K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+5K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+5K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+5K200312Tryptik TiSpineart20202—
+5K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+5K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+5K191796Neo Cage SystemNeo Medical SA20190—
+5K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+5K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+5K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+5K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+5K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+5K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+5K190488ProLift Expandable SystemLife Spine, Inc.201916—
+5K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+5K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+5K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+5K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K181048Neo Cage System TMNeo Medical SA20191—
+5K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+5K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+5K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+5K182470Plateau Spacer SystemLife Spine20180—
+5K181829Velofix TLIF CageU&I Corporation20181—
+5K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+5K181818Scarlet AL-TSpineart201864—
+5K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+5K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+5K181203Juliet TiSpineart20181—
+5K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+5K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+5K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+5K172816TiGer Shark™ SystemChoicespine, LP201859—
+5K173702Juliet Ti LLSpineart20182—
+5K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+5K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+5K172756Varian cageMedyssey USA, Inc.20171—
+5K170235Lucent®Spinal Elements, Inc.2017107—
+5K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+5K171519FLXfit™Expanding Orthopedics, Inc.2017711
+5K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+5K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+5K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+5K162921Navigated Instrument SystemOrthofix, Inc.20175—
+5K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+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—
+5K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+5K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+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