510(k) Report

Devices descending from P970015

1,426 later devices reach Inter Fix Threaded Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+3K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+3K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+3K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+3K192906Mecta-C Stand AloneMedacta International S.A.20201—
+3K193521Steerable Plateau TiLife Spine, Inc.20201—
+3K192993Scarlet AL-TSpineart20201—
+3K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+3K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+3K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+3K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+3K191134IB3D AlifMedicrea International SA20191—
+3K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+3K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+3K183407Triton CageMedyssey USA, Inc.20190—
+3K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+3K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+3K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+3K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+3K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+3K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+3K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+3K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+3K191263Idys ALIF TiVacClariance, Sas20190—
+3K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+3K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+3K190380nvcNvision Biomedical Technologies, Inc.20193—
+3K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+3K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+3K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+3K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+3K181899Roccia® PlifSilony Medical GmbH20180—
+3K181625Life Spine Resolute™ Threaded Cage SystemLife Spine, Inc.20180—
+3K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+3K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+3K182470Plateau Spacer SystemLife Spine20180—
+3K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+3K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+3K181818Scarlet AL-TSpineart201864—
+3K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+3K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+3K181397DualXInnovasive, Inc.201815—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K181337Sypher Spacer SystemBiogennix, LLC20180—
+3K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+3K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+3K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+3K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+3K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+3K180695FBC 921 (Alif)Fbc Device Aps20180—
+3K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+3K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+3K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+3K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+3K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K172484A-CIFT SoloFuseSpinefrontier, Inc.201871
+3K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+3K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+3K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+3K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+3K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+3K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+3K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+3K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+3K172828Double Medical Cage SystemDouble Medical Technology, Inc.20181—
+3K171312FortiCore®Nanovis, LLC20183—
+3K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+3K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+3K172419Velofix™ TLIF CageU&I Corporation20172—
+3K172424Velofix™ SA Cervical CageU&I Corporation201751
+3K170341Medussa-PL CageMedyssey USA, Inc.20174—
+3K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+3K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+3K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+3K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+3K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+3K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+3K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+3K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+3K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+3K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+3K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+3K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+3K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+3K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K153665Prow Fusion-LNlt Spine, Ltd.20160—
+3K161129Pillar SA PTCOrthofix, Inc.201619—
+3K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+3K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+3K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+3K153621Juliet® TiSpineart2016751
+3K160631Keos Lumbar IBFDKeos20161—
+3K153436LATERAL Spine Truss System4Web, Inc.20165—
+3K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—