510(k) Report

Devices descending from K073649

278 later devices reach Bengal Stackable Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190284Bengal Stackable Cage SystemMedos International SARL20190—
+1K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+1K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+1K140759Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar…Medos International SARL2014204—
+1K131724Pioneer Maxfuse Vertebral Body Replacement DevicePioneer Surgical Technology, Inc.201373—
+1K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.201031—
+2K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+2K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+2K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+2K151352CONCORDE Bullet Spinal SystemMedos International SARL20153—
+2K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+2K142005SpineFab Vertebral Body Replacement (VBR) SystemOxford Performance Materials201513—
+2K142030STGC-LordoticCardinal Spine, LLC201558—
+2K131636Polarus ConnectAcumed, LLC20130—
+2K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+2K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+2K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+2K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+2K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029—
+3K253158VyBrate™ VBR SystemVy Spine, LLC20260—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+3K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+3K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+3K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+3K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+3K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+3K170235Lucent®Spinal Elements, Inc.2017107—
+3K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+3K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+3K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+3K160995NEOVIEW Plating SystemIn2bones Sas201624
+3K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+3K152568C-VBRCardinal Spine, LLC201657—
+3K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+3K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+3K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+3K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+3K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+4K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+4K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+4K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+4K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+4K230026SqualeImplanet, S.A.20230—
+4K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+4K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+4K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+4K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+4K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+4K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+4K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+4K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+4K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+4K182584Lucent® XPSpinal Elements, Inc.20183—
+4K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+4K173893TrabisColigne AG20180—
+4K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.201755—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K163589SIGN IM NailSign Fracture Care International20170—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+5K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+5K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+5K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+5K234150Lucent® XPSpinal Elements20240—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+5K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+5K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K230583Tryptik TiSpineart SA20231—
+5K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+5K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+5K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+5K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+5K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+5K192897icotec Cervical CageIcotec AG20201—
+5K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+5K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+5K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+5K190147COLOSSEUM MeshGlobus Medical, Inc.20190—
+5K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+5K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+5K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+5K173982FORTIFY Corpectomy SpacersGlobus Medical, Inc.20188—
+5K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+6K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+6K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+6K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+6K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+6K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—