510(k) Report

Devices descending from K133577

256 later devices reach Clydesdale (R) Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+1K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+1K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+1K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+1K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+1K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+2K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+2K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+2K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+2K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+2K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+2K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+2K201671A-Link ZAcuity Surgical Devices, LLC202125—
+2K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+2K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+2K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+2K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+2K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+2K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+2K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+2K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+2K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+3K260810Anteralign LS coverplateTyber Medical, LLC20260—
+3K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K252742Navigated InstrumentsTyber Medical, LLC20251—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+3K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+3K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+3K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+3K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K223494CD Horizon Spinal SystemMedtronic202317—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+3K222561AlignAcuity Surgical Devices, LLC202214—
+3K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+3K220610SOLO-LAurora Spine, Inc.20220—
+3K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+3K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+3K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+3K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+3K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+3K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+3K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+3K181397DualXInnovasive, Inc.201815—
+3K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+3K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+3K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+3K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+4K261408SABER-XA SystemElevation Spine20260—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+4K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+4K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+4K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K253331PressON Spinal Fixation SystemNexus Spine20250—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+4K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+4K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+4K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+4K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+4K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K232432E3D™-A Interbody SystemEvolution Spine20248—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—