510(k) Report

Devices descending from K100175

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+3K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+3K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+3K163595IMPIX 3D Print CagesMedicrea International SA2017282
+3K172083Idys™ ALIF SystemClariance, Sas20177—
+3K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+3K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+3K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+3K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+3K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+3K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+3K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+3K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+3K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+3K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+3K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+3K150847Foundation Interbody DevicesCorelink, LLC201529—
+3K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+3K142744Mecta-C TiPEEKMedacta International201512—
+3K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+3K140474Juliet OLSpineart2014120—
+3K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+3K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+3K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+3K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+3K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+3K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K252742Navigated InstrumentsTyber Medical, LLC20251—
+4K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+4K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+4K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+4K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+4K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+4K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+4K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+4K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+4K223326Axiom PSR SystemRestor3D202301
+4K223494CD Horizon Spinal SystemMedtronic202317—
+4K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+4K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+4K221172FOCUS Interbody SystemOc Medical Devices20220—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+4K201793EDEN Peek CageJmt Co., Ltd.20210—
+4K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+4K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+4K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+4K201671A-Link ZAcuity Surgical Devices, LLC202125—
+4K200919Idys ALIF 3DTiClariance20210—
+4K202032Idys LLIF 3DTiClariance, Sas20210—
+4K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+4K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+4K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+4K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+4K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+4K191134IB3D AlifMedicrea International SA20191—
+4K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+4K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+4K191263Idys ALIF TiVacClariance, Sas20190—
+4K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+4K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+4K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+4K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+4K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+4K182721Choice Spine Navigation SystemChoicespine, LP20192—
+4K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+4K181899Roccia® PlifSilony Medical GmbH20180—
+4K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+4K181397DualXInnovasive, Inc.201815—
+4K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+4K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+4K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+4K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+4K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+4K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+4K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+4K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+4K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+4K163180Hubble IIOrbbo Surgical, LLC20160—
+4K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K161379ELSA SpacersGlobus Medical, Inc.2016155—
+4K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—