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
+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—
+2K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+2K133053Milestone Spinal SystemWeigao Orthopaedic Device Co., Ltd.20142—
+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—
+2K133286Midline (TM)Centinel Spine, Inc.2014460—
+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—
+2K130853Idys (TM) CClariance20132—
+2K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+2K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+2K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+2K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+2K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+2K130461Stalif XCentinel Spine, Inc.201313—
+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—
+2K124034Mectalif AnteriorMedacta International201311—
+2K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+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—
+2K120401Alamo TAlliance Partners, LLC20121—
+2K122047Alamo PAlliance Partners, LLC20120—
+2K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+2K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+2K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+2K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+2K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+2K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+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—
+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
+2K110177Helena SystemRoyal Oak Medical Devices20110—
+2K110067LP CageMedyssey Co, Ltd.201115—
+2K103369Vault Alif SystemSpinal USA201110—
+2K102067Endoskeleton toTitan Spine, LLC2010337—
+2K102090Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant SystemSpine Smith Partners L.P.20104731
+2K101301Stalif MidlineCentinel Spine2010474—
+2K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+2K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+2K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+2K101085Spinesmith Cynch Spinal SystemSpine Smith Partners L.P.201001
+2K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+2K100175Clydesdale Spinal SystemMedtronic Sofamor Danek20101,008—
+2K083798Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar IbfMedicrea Technologies2010322
+2K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+2K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+2K091813Intrepid Spinal SystemMedtronic Sofamor Danek2009719—
+2K083475Lucent MagnumSpinal Elements, Inc.2009834—
+2K083167Phenix Cervical Interbody DeviceSpinal Devices, LLC200914—
+2K081196Spinal Usa VBR SystemSpinal USA200813—
+2K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+2K081880Atlas Spine SpacerAtlas Spine, Inc.20080—
+2K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+2K081711Lucent Magnum+Spinal Elements, Inc.20080—
+2K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531
+2K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20087751
+3K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+3K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+3K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+3K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—