510(k) Report

Devices descending from P950019

1,482 later devices reach Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+3K201769Cavetto [MAX] Cervical Cage SystemNeurostructures, Inc.20200—
+3K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+3K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+3K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+3K192897icotec Cervical CageIcotec AG20201—
+3K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+3K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+3K193521Steerable Plateau TiLife Spine, Inc.20201—
+3K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+3K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+3K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+3K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+3K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+3K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+3K183407Triton CageMedyssey USA, Inc.20190—
+3K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+3K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+3K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+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—
+3K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+3K190380nvcNvision Biomedical Technologies, Inc.20193—
+3K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+3K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+3K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+3K181899Roccia® PlifSilony Medical GmbH20180—
+3K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+3K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+3K182470Plateau Spacer SystemLife Spine20180—
+3K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+3K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+3K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+3K181818Scarlet AL-TSpineart201864—
+3K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+3K181337Sypher Spacer SystemBiogennix, LLC20180—
+3K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+3K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+3K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+3K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+3K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+3K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+3K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+3K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+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—
+3K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+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—
+3K173283Reliance Lumbar IBF SystemReliance Medical Systems, LLC20189—
+3K173702Juliet Ti LLSpineart20182—
+3K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+3K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+3K172756Varian cageMedyssey USA, Inc.20171—
+3K172419Velofix™ TLIF CageU&I Corporation20172—
+3K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+3K172424Velofix™ SA Cervical CageU&I Corporation201751
+3K163595IMPIX 3D Print CagesMedicrea International SA2017282
+3K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+3K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+3K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+3K171140Matrixx SystemNexxt Spine, LLC2017145—
+3K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+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—
+3K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+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—
+3K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+3K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+3K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+3K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+3K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+3K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+3K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+3K153665Prow Fusion-LNlt Spine, Ltd.20160—
+3K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+3K161129Pillar SA PTCOrthofix, Inc.201619—
+3K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+3K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+3K153621Juliet® TiSpineart2016751
+3K160631Keos Lumbar IBFDKeos20161—
+3K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+3K153436LATERAL Spine Truss System4Web, Inc.20165—