510(k) Report

Devices descending from K100175

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+7K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+7K193258ProLift Expandable SystemLife Spine, Inc.20203—
+7K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+7K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+7K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+7K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+7K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+7K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+7K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+7K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+7K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+7K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+7K190680Favo S-TlifSilony Medical GmbH20190—
+7K183064TxTi IBF SystemInnovasis, Inc.2019481
+7K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+7K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+7K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+7K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+7K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+7K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+7K182477Cervical SpacerAdditive Implants, LLC201915—
+7K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+7K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+7K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+7K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+7K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+7K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+7K181014Tritanium PL CageStryker Spine2018137—
+7K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+7K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+7K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+7K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+7K171312FortiCore®Nanovis, LLC20183—
+7K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+7K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+7K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+7K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+7K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+7K171140Matrixx SystemNexxt Spine, LLC2017145—
+7K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+7K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+7K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+7K170055CAPRI Corpectomy Cage SystemK2m201711—
+7K163364MOJAVE Expandable Interbody SystemK2m201725—
+7K162264Cascadia Interbody SystemK2m, Inc.2016169—
+7K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+7K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+7K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+7K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+8K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+8K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+8K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+8K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K261067BEE PLIF CageNGMedical GmbH20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+8K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+8K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+8K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+8K250769Dakota LP SystemPrecision Spine, Inc.20250—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+8K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+8K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+8K250556Porous Biologic ScaffoldVentris Medical20250—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+8K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+8K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+8K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+8K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+8K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+8K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+8K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+8K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+8K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+8K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+8K240442MagnetOs PuttyKuros Biosciences B.V20243—
+8K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+8K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+8K240458Synthetic Bone PuttyVentris Medical20242—
+8K240459Cerament Bone Void FillerBonesupport AB20240—
+8K232347MagnetOs GranulesKuros Biosciences B.V20242—
+8K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+8K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+8K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+8K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+8K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+8K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+8K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+8K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—