510(k) Report

Devices descending from K013382

1,110 later devices reach Modification to: Stackable Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+6K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+6K211306LabyrinthZavation Medical Products, LLC20213—
+6K200919Idys ALIF 3DTiClariance20210—
+6K202032Idys LLIF 3DTiClariance, Sas20210—
+6K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+6K200429BEE CagesNGMedical GmbH202111—
+6K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+6K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+6K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+6K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+6K200316UNiD IB3D ALIFMedicrea International SA20200—
+6K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+6K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+6K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+6K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+6K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+6K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+6K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+6K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+6K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+6K200312Tryptik TiSpineart20202—
+6K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+6K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+6K193258ProLift Expandable SystemLife Spine, Inc.20203—
+6K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+6K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+6K191796Neo Cage SystemNeo Medical SA20190—
+6K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+6K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+6K1803473d CageFims Co., Ltd.20190—
+6K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+6K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+6K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+6K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+6K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+6K183064TxTi IBF SystemInnovasis, Inc.2019481
+6K191263Idys ALIF TiVacClariance, Sas20190—
+6K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+6K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+6K182349Concorde LiftMedos International SARL20190—
+6K183092Kuros TLIF CageKuros Biosciences B.V20190—
+6K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+6K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+6K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+6K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+6K181048Neo Cage System TMNeo Medical SA20191—
+6K182477Cervical SpacerAdditive Implants, LLC201915—
+6K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+6K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+6K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+6K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+6K182470Plateau Spacer SystemLife Spine20180—
+6K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+6K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+6K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+6K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+6K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+6K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+6K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+6K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+6K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+6K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+6K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+6K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+6K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+6K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+6K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+6K173537Concorde Lift™Medos International SARL20181—
+6K172816TiGer Shark™ SystemChoicespine, LP201859—
+6K171312FortiCore®Nanovis, LLC20183—
+6K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+6K173702Juliet Ti LLSpineart20182—
+6K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+6K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+6K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+6K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+6K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+6K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+6K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+6K172065Scarlet AC-TSpineart20172—
+6K171519FLXfit™Expanding Orthopedics, Inc.2017711
+6K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+6K171140Matrixx SystemNexxt Spine, LLC2017145—
+6K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+6K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+6K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+6K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+6K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+6K162262Tritanium® PL CageStryker2016132—
+6K162264Cascadia Interbody SystemK2m, Inc.2016169—
+6K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+6K160856SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.20165—
+6K160955Tritanium® PL CageStryker2016178—
+6K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+6K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+6K153695Biomet Spine Fusion SystemBiomet Spine, LLC201632