510(k) Report

Devices descending from P980048

1,422 later devices reach Bak/Cervical (Bak/C) Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+3K183243Velofix TLIF CageU&I Corporation20190—
+3K183064TxTi IBF SystemInnovasis, Inc.2019481
+3K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+3K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+3K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+3K190380nvcNvision Biomedical Technologies, Inc.20193—
+3K183092Kuros TLIF CageKuros Biosciences B.V20190—
+3K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+3K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+3K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+3K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+3K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+3K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+3K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+3K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+3K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+3K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+3K181899Roccia® PlifSilony Medical GmbH20180—
+3K182584Lucent® XPSpinal Elements, Inc.20183—
+3K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+3K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+3K181829Velofix TLIF CageU&I Corporation20181—
+3K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+3K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+3K181397DualXInnovasive, Inc.201815—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+3K181337Sypher Spacer SystemBiogennix, LLC20180—
+3K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+3K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+3K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+3K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+3K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+3K180695FBC 921 (Alif)Fbc Device Aps20180—
+3K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+3K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+3K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+3K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+3K180724SPIRA Open Matrix LLIFCamber Spine Technologies, LLC201810—
+3K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+3K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+3K172480icotec Interbody Cage SystemIcotec AG20185—
+3K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+3K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+3K172484A-CIFT SoloFuseSpinefrontier, Inc.201871
+3K172568CervagePrecifit Medical, Ltd.20181—
+3K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+3K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+3K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+3K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+3K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+3K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+3K173128Alamo® CAlliance Partners, LLC20182—
+3K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+3K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+3K171312FortiCore®Nanovis, LLC20183—
+3K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+3K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+3K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+3K172020Arlington PLIF/TLIF CageSignature Orthopaedics Pty, Ltd.20170—
+3K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+3K170235Lucent®Spinal Elements, Inc.2017107—
+3K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+3K170341Medussa-PL CageMedyssey USA, Inc.20174—
+3K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+3K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+3K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+3K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+3K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+3K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+3K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+3K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+3K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+3K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+3K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+3K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+3K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+3K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+3K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+3K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+3K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+3K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+3K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+3K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+3K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+3K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+3K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+3K163265Kepler IIOrbbo Surgical, LLC20170—
+3K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+3K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+3K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+3K162694Ayers Rock Cervical interbody fusion systemSpineway20170—
+3K163180Hubble IIOrbbo Surgical, LLC20160—
+3K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+3K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+3K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+3K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+3K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+3K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—