510(k) Report

Devices descending from K083026

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+3K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+3K153621Juliet® TiSpineart2016751
+3K153436LATERAL Spine Truss System4Web, Inc.20165—
+3K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+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—
+3K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+3K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+3K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+3K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+3K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+3K142277Juliet POSpineart2014119—
+3K140474Juliet OLSpineart2014120—
+3K133192Mectalif TipeekMedacta International201416—
+3K123758Tasmin RSignus Medizintechnik GmbH20141—
+3K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+3K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+3K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+3K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+3K131671MectalifMedacta International201322—
+3K124034Mectalif AnteriorMedacta International201311—
+3K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+3K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+3K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+3K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+3K120024Mectalif TransforaminalMedacta International S.A.201223—
+3K112862Mecta-CMedacta International201114—
+4K261049Scala® TLSpineart SA20260—
+4K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+4K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+4K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.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—
+4K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+4K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+4K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+4K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+4K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+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—
+4K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+4K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+4K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+4K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+4K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+4K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+4K223494CD Horizon Spinal SystemMedtronic202317—
+4K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+4K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+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—
+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—
+4K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+4K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+4K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+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—
+4K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+4K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+4K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+4K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+4K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+4K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+4K201671A-Link ZAcuity Surgical Devices, LLC202125—
+4K200919Idys ALIF 3DTiClariance20210—
+4K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—