510(k) Report

Devices descending from K080615

564 later devices reach Endoskeleton TA Interbody Fusion Device (Ibd) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+5K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+5K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+5K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+5K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+5K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+5K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+5K191134IB3D AlifMedicrea International SA20191—
+5K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+5K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+5K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+5K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+5K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+5K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+5K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+5K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+5K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+5K181397DualXInnovasive, Inc.201815—
+5K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+5K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+5K172816TiGer Shark™ SystemChoicespine, LP201859—
+5K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+5K172419Velofix™ TLIF CageU&I Corporation20172—
+5K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+5K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+5K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+5K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+6K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+6K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+6K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+6K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+6K250556Porous Biologic ScaffoldVentris Medical20250—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+6K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+6K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+6K240442MagnetOs PuttyKuros Biosciences B.V20243—
+6K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+6K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+6K240458Synthetic Bone PuttyVentris Medical20242—
+6K240459Cerament Bone Void FillerBonesupport AB20240—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K232347MagnetOs GranulesKuros Biosciences B.V20242—
+6K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+6K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+6K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+6K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+6K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K232315Catalyst Bone Void FillerOssdsign AB20237—
+6K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+6K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+6K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+6K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+6K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+6K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+6K213417Ghost Spacer SystemLife Spine, Inc.20220—
+6K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—