510(k) Report

Devices descending from K112405

296 later devices reach Clydesdales Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+1K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+1K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+1K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+1K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+2K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+2K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+2K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+2K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+2K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+2K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+2K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+2K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+2K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+2K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+2K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+2K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+2K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+2K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+2K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+2K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+2K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+2K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+3K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+3K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+3K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+3K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+3K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+3K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+3K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+3K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+3K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+3K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+3K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+3K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+3K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+3K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+3K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K182721Choice Spine Navigation SystemChoicespine, LP20192—
+3K181963ostaPek Interbody Fusion CagesColigne AG20181—
+3K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+3K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+3K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+3K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+3K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+4K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K252742Navigated InstrumentsTyber Medical, LLC20251—
+4K252322SIros-X SystemGenesys Spine20250—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+4K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+4K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+4K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+4K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+4K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+4K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+4K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+4K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+4K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+4K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+4K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+4K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+4K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+4K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+4K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+4K221244CD Horizon™ Spinal SystemMedtronic202220—
+4K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+4K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+4K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+4K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+4K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+4K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—