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
+2K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+2K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+2K163494Summit Spine Channel Cervical Interbody Fusion SystemSummit Spine20171—
+2K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+2K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+2K163246Leva Anterior Expandable Spacer SystemSpine Wave, Inc.20170—
+2K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Evolution Spine, LLC20160—
+2K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+2K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+2K160874Nanovis Intervertebral Body Fusion System and FortiCore®Nanovis, LLC20164—
+2K160463Reliance Lumbar IBF SystemReliance Medical Systems, LLC201611—
+2K160324Cervical Interbody Fusion SystemEvolution Spine, LLC20162—
+2K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+2K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+2K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+2K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+2K151481Sahara Stabilization SystemK2m, Inc.20155—
+2K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.20158—
+2K151819Integrity Spine Lumbar Interbody Fusion SystemIntegrity Spine Lumbar Interbody Fusion System20154—
+2K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+2K150812Genesys Spine Apache Cervical Interbody Fusion SystemGenesys Spine201512—
+2K150847Foundation Interbody DevicesCorelink, LLC201529—
+2K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+2K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+2K151581Leva Spacer SystemSpine Wave, Inc.20156—
+2K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+2K140348Interbody CageEisertech, LLC2015235—
+2K150285Leva (TM) Spacer SystemSpine Wave, Inc.20157—
+2K141798Sypher Spacer SystemBiogennix, LLC20151—
+2K142328nvcNvision Biomedical Technologies, LLC20144—
+2K141135Juliet LLSpineart2014146—
+2K142594nva, nvp, nvtNvision Biomedical Technologies, LLC20144—
+2K141333Arena-C Tifuse Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.20140—
+2K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+2K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+2K142026Spinefrontier Arena-C HA Peek Cervical Intervertebral Body Fusion DeviceSpinefrontier, Inc.2014190—
+2K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+2K141337Arena-CSpinefrontier, Inc.20141—
+2K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+2K133053Milestone Spinal SystemWeigao Orthopaedic Device Co., Ltd.20142—
+2K140055Endoskeleton (R) TL Interbody Fusion DeviceTitan Spine, LLC2014267—
+2K132738Cogent Med-LifCogent Spine, LLC201413—
+2K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+2K133893Sterispine LC CageSafe Orthopaedics20141—
+2K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+2K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+2K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+2K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+2K130913Genesys Spine Apache Lateral Lumbar Interbody Fusion SystemGenesys Spine201314—
+2K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+2K130317Genesys Spine Apache Ibfd Star Cervical SystemGenesys Spine20139—
+2K133126K7 Lumbar SpacersK7, LLC20131—
+2K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+2K132718Integrity Spine Core SystemIntegrity Spine20131—
+2K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+2K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+2K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+2K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+2K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+2K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+2K131671MectalifMedacta International201322—
+2K121178Transcorp Acif SystemTranscorp, Inc.20130—
+2K131372Mobis IISignus Medizintechnik GmbH2013462—
+2K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+2K130548Epicage Interbody Fusion DeviceAlphatec Spine, Inc.2013602—
+2K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+2K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+2K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+2K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+2K123969XiphosDifusion Technologies201314—
+2K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+2K123388K7C SpacerK7, LLC20130—
+2K120869Anchor-L Lumbar CageStryker Spine2012638—
+2K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+2K120401Alamo TAlliance Partners, LLC20121—
+2K122047Alamo PAlliance Partners, LLC20120—
+2K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+2K122317Tetris IISignus Medizintechnik GmbH20122—
+2K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+2K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+2K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+2K113478Plif CageEisertech, LLC2012269—
+2K120024Mectalif TransforaminalMedacta International S.A.201223—
+2K113518Arena-C Cervical Intervertebral Body Fusion SystemSpinefrontier, Inc.2012193—
+2K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+2K113138Aleutian SystemK2m, Inc.2012549—
+2K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+2K111512Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc.2011762—
+2K112014Zyston Straight Spacer SystemBiomet Spine2011174—
+2K110659Medical Concepts Interbody Fusion SystemMedical Concepts, Inc.20111—
+2K111626Endoskeleton (R) TasTitan Spine, LLC2011273—
+2K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011355—
+2K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+2K111569Plateau Spacer SystemLife Spine2011181—
+2K110927MectalifMedacta International2011301
+2K103111Forza Spacer SystemOrthofix, Inc.20113431
+2K102090Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant SystemSpine Smith Partners L.P.20104731
+2K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+2K100865Ava Navigator Peek Spacers, Model 48392XXX, 48393XXXStryker Spine2010637—
+2K100743Atlas Spine Pivoting SystemAtlas Spine, Inc.20104—