510(k) Report

Devices descending from K080822

708 later devices reach VU Apod Intervertabral Body Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+7K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+7K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+7K183243Velofix TLIF CageU&I Corporation20190—
+7K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+7K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+7K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+7K182584Lucent® XPSpinal Elements, Inc.20183—
+7K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+7K181829Velofix TLIF CageU&I Corporation20181—
+7K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+7K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+7K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+7K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+7K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+7K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+8K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+8K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+8K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+8K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+8K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K250769Dakota LP SystemPrecision Spine, Inc.20250—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+8K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+8K253331PressON Spinal Fixation SystemNexus Spine20250—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+8K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+8K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+8K234150Lucent® XPSpinal Elements20240—
+8K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+8K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+8K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+8K223418DeGen Impulse AM™ SystemDegen Medical20236—
+8K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+8K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+8K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+8K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+8K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+8K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+8K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+8K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+8K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+8K212358Romero Cervical CageSpineup, Inc.20226—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+8K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+8K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+8K202637F3D Corpectomy SystemCorelink, LLC20201—
+8K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+8K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+8K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+8K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+8K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+8K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+8K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+8K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+8K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+9K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+9K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+9K252742Navigated InstrumentsTyber Medical, LLC20251—
+9K252322SIros-X SystemGenesys Spine20250—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+9K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+9K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+9K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+9K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+9K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+9K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+9K230026SqualeImplanet, S.A.20230—
+9K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+9K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+9K203003Pantheon IBFDPantheon Spinal20210—
+9K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+9K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+9K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+10K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—