510(k) Report

Devices descending from K094025

838 later devices reach Crescent Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+7K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+7K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+7K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+7K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+7K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+7K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+7K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+7K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+7K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+7K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+7K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+7K172941CASCADIA Interbody SystemK2m201852—
+7K172009Cascadia Interbody SystemK2m, Inc.2017433
+7K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+7K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+7K171704CAPRI Corpectomy Cage SystemK2m201710—
+7K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+7K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+7K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+8K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+8K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+8K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+8K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K261279DeltaNEC Interbody SystemNexus Spine20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+8K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+8K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+8K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+8K243474MagnetOs MISKuros Biosciences B.V20250—
+8K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+8K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+8K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+8K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+8K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+8K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+8K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+8K240453ReBOSSISOrthorebirth Co., Ltd.202402
+8K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+8K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+8K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+8K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+8K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+8K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+8K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+8K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+8K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+8K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+8K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+8K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+8K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+8K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+8K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+8K223251Hexanium PLIFSpinevision, S.A.S.20220—
+8K221578Hexanium ACIFSpinevision, S.A.S.20224—
+8K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+8K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+8K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+8K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+8K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+8K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+8K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+8K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+8K202637F3D Corpectomy SystemCorelink, LLC20201—
+8K201287Impulse Interbody Fusion SystemDegen Medical20208—
+8K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+8K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+8K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+8K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+8K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+8K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+8K1803473d CageFims Co., Ltd.20190—
+8K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+8K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+8K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+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—
+9K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—