510(k) Report

Devices descending from K083026

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+8K200070ARx Spinal SystemLife Spine, Inc.20209—
+8K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+8K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+8K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+8K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+8K193258ProLift Expandable SystemLife Spine, Inc.20203—
+8K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+8K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+8K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+8K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+8K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+8K190680Favo S-TlifSilony Medical GmbH20190—
+8K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+8K183064TxTi IBF SystemInnovasis, Inc.2019481
+8K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+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—
+8K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+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—
+8K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+8K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+8K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+9K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+9K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+9K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K261279DeltaNEC Interbody SystemNexus Spine20260—
+9K261067BEE PLIF CageNGMedical GmbH20260—
+9K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+9K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+9K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+9K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+9K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+9K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+9K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+9K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+9K243474MagnetOs MISKuros Biosciences B.V20250—
+9K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+9K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+9K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+9K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+9K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+9K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+9K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+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—
+9K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+9K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+9K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+9K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+9K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+9K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+9K223251Hexanium PLIFSpinevision, S.A.S.20220—
+9K221578Hexanium ACIFSpinevision, S.A.S.20224—
+9K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+9K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+9K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+9K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+9K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+9K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+9K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+9K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+9K211413BEE PLIF CageNGMedical GmbH20211—
+9K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+9K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+9K210728CONDUIT InstrumentsMedos International SARL20215—
+9K210549ARx Spinal SystemLife Spine, Inc.20211—
+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—
+9K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+9K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+9K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+9K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+9K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+9K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+9K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+9K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+9K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+9K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—