510(k) Report

Devices descending from K100175

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+9K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+9K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+9K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+9K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+9K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+9K240453ReBOSSISOrthorebirth Co., Ltd.202402
+9K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+9K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+9K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+9K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+9K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+9K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+9K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+9K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+9K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+9K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K223251Hexanium PLIFSpinevision, S.A.S.20220—
+9K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+9K221578Hexanium ACIFSpinevision, S.A.S.20224—
+9K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+9K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+9K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+9K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+9K220025ARx® Spinal SystemLife Spine, Inc.20220—
+9K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+9K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+9K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+9K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+9K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+9K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+9K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+9K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+9K202637F3D Corpectomy SystemCorelink, LLC20201—
+9K201287Impulse Interbody Fusion SystemDegen Medical20208—
+9K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+9K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+9K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+9K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+9K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+9K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+9K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+9K200070ARx Spinal SystemLife Spine, Inc.20209—
+9K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+9K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+9K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+9K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+9K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+9K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+9K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+9K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+9K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+9K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+10K253545Vulcan Spinal SystemK2m, Inc.20260—
+10K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+10K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+10K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+10K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+10K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+10K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+10K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+10K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+10K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+10K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+10K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+10K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+10K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+10K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+10K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+10K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+10K212358Romero Cervical CageSpineup, Inc.20226—
+10K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+10K210549ARx Spinal SystemLife Spine, Inc.20211—
+10K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+10K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+10K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+10K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+10K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+10K171425Concorde LiftMedos International SARL201782
+11K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+11K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+11K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+11K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+11K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+11K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+11K230026SqualeImplanet, S.A.20230—
+11K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+11K211306LabyrinthZavation Medical Products, LLC20213—