510(k) Report

Devices descending from K100175

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+8K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+8K232315Catalyst Bone Void FillerOssdsign AB20237—
+8K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+8K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+8K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+8K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+8K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+8K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+8K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+8K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+8K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+8K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+8K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+8K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+8K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+8K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+8K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+8K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+8K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+8K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+8K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+8K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+8K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+8K211413BEE PLIF CageNGMedical GmbH20211—
+8K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+8K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+8K210359Hexanium TLIFSpinevision, S.A.S.20211—
+8K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+8K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+8K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+8K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+8K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+8K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+8K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+8K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+8K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+8K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+8K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+8K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+8K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+8K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+8K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+8K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+8K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+8K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+8K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+8K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+8K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+8K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+8K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+8K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+8K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+8K191575ARx Spinal SystemLife Spine, Inc.201910—
+8K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+8K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+8K183092Kuros TLIF CageKuros Biosciences B.V20190—
+8K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+8K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+8K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+8K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+8K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+8K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+8K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+8K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+8K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+8K172941CASCADIA Interbody SystemK2m201852—
+8K172009Cascadia Interbody SystemK2m, Inc.2017433
+8K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+8K171704CAPRI Corpectomy Cage SystemK2m201710—
+8K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+8K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+8K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+8K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+9K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+9K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+9K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+9K261279DeltaNEC Interbody SystemNexus Spine20260—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+9K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+9K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+9K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+9K243474MagnetOs MISKuros Biosciences B.V20250—
+9K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+9K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+9K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+9K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+9K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+9K242797OsteoFlo HydroFiberSurGenTec, LLC20241—