510(k) Report

Devices descending from K090166

683 later devices reach Avs Anterior Large Peek Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+6K191134IB3D AlifMedicrea International SA20191—
+6K1803473d CageFims Co., Ltd.20190—
+6K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+6K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+6K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+6K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+6K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+6K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+6K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+6K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+6K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+6K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+6K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+6K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+6K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+6K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+6K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+6K182584Lucent® XPSpinal Elements, Inc.20183—
+6K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+6K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+6K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+6K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+6K181818Scarlet AL-TSpineart201864—
+6K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+6K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+6K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+6K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+6K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+6K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+6K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+6K181203Juliet TiSpineart20181—
+6K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+6K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+6K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+6K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+6K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+6K173702Juliet Ti LLSpineart20182—
+6K172009Cascadia Interbody SystemK2m, Inc.2017433
+6K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+6K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+6K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+6K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+6K171704CAPRI Corpectomy Cage SystemK2m201710—
+6K171425Concorde LiftMedos International SARL201782
+6K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+6K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+6K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+6K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+7K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+7K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+7K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+7K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+7K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+7K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+7K253545Vulcan Spinal SystemK2m, Inc.20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+7K250769Dakota LP SystemPrecision Spine, Inc.20250—
+7K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+7K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+7K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+7K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+7K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+7K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+7K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+7K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+7K250556Porous Biologic ScaffoldVentris Medical20250—
+7K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+7K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+7K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+7K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+7K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242589Scarlet® AL-TSpineart SA20240—
+7K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+7K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+7K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+7K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+7K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+7K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+7K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—