510(k) Report

Devices descending from K132897

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+1K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+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—
+1K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+1K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+1K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+1K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+1K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+1K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+1K153665Prow Fusion-LNlt Spine, Ltd.20160—
+1K153436LATERAL Spine Truss System4Web, Inc.20165—
+1K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+2K261408SABER-XA SystemElevation Spine20260—
+2K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+2K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+2K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+2K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+2K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+2K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+2K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+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—
+2K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+2K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+2K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+2K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+2K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+2K172083Idys™ ALIF SystemClariance, Sas20177—
+2K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+2K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+2K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+2K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+2K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+2K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+3K260810Anteralign LS coverplateTyber Medical, LLC20260—
+3K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+3K252742Navigated InstrumentsTyber Medical, LLC20251—
+3K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+3K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+3K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+3K223326Axiom PSR SystemRestor3D202301
+3K223494CD Horizon Spinal SystemMedtronic202317—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+3K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+3K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+3K201671A-Link ZAcuity Surgical Devices, LLC202125—
+3K200919Idys ALIF 3DTiClariance20210—
+3K202032Idys LLIF 3DTiClariance, Sas20210—
+3K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+3K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+3K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+3K191134IB3D AlifMedicrea International SA20191—
+3K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+3K191263Idys ALIF TiVacClariance, Sas20190—
+3K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+3K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+4K261049Scala® TLSpineart SA20260—
+4K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+4K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K260837VersaLift Expandable SystemLife Spine, Inc.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—
+4K253260ORIO-3D Cage SystemSpineCraft20260—
+4K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K253331PressON Spinal Fixation SystemNexus Spine20250—
+4K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+4K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+4K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+4K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+4K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—