510(k) Report

Devices descending from K083026

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+7K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+7K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+7K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+7K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+7K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+7K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+7K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+7K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+7K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+7K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+7K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+7K234150Lucent® XPSpinal Elements20240—
+7K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+7K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+7K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+7K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+7K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+7K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+7K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+7K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+7K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+7K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+7K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+7K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+7K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+7K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+7K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+7K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+7K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+7K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+7K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+7K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+7K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+7K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+7K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+7K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+7K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+7K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+7K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+7K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+7K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+7K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+7K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+7K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+7K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+7K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+7K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+7K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+7K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+7K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+7K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+7K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+7K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+7K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+7K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+7K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+7K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+7K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+7K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+7K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+7K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+7K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+7K192897icotec Cervical CageIcotec AG20201—
+7K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+7K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+7K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+7K193521Steerable Plateau TiLife Spine, Inc.20201—
+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—
+7K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+7K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+7K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+7K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+7K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+7K191575ARx Spinal SystemLife Spine, Inc.201910—
+7K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+7K183243Velofix TLIF CageU&I Corporation20190—
+7K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+7K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+7K182477Cervical SpacerAdditive Implants, LLC201915—
+7K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+7K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+7K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+7K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+7K181014Tritanium PL CageStryker Spine2018137—
+7K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+7K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—