510(k) Report

Devices descending from P950002

1,681 later devices reach Bak Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K192906Mecta-C Stand AloneMedacta International S.A.20201—
+3K193521Steerable Plateau TiLife Spine, Inc.20201—
+3K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+3K190284Bengal Stackable Cage SystemMedos International SARL20190—
+3K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+3K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+3K191134IB3D AlifMedicrea International SA20191—
+3K1803473d CageFims Co., Ltd.20190—
+3K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+3K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+3K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+3K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+3K183407Triton CageMedyssey USA, Inc.20190—
+3K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+3K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+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—
+3K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+3K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+3K190680Favo S-TlifSilony Medical GmbH20190—
+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—
+3K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+3K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+3K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+3K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+3K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+3K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+3K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+3K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+3K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+3K181899Roccia® PlifSilony Medical GmbH20180—
+3K181625Life Spine Resolute™ Threaded Cage SystemLife Spine, Inc.20180—
+3K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+3K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+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—
+3K181397DualXInnovasive, Inc.201815—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+3K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+3K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+3K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+3K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+3K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+3K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+3K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+3K180695FBC 921 (Alif)Fbc Device Aps20180—
+3K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+3K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+3K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+3K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+3K172480icotec Interbody Cage SystemIcotec AG20185—
+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
+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—
+3K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+3K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+3K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+3K173128Alamo® CAlliance Partners, LLC20182—
+3K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+3K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+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—
+3K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+3K173702Juliet Ti LLSpineart20182—
+3K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+3K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+3K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+3K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+3K172756Varian cageMedyssey USA, Inc.20171—
+3K172419Velofix™ TLIF CageU&I Corporation20172—
+3K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+3K172020Arlington PLIF/TLIF CageSignature Orthopaedics Pty, Ltd.20170—
+3K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+3K170235Lucent®Spinal Elements, Inc.2017107—
+3K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+3K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+3K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+3K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+3K170341Medussa-PL CageMedyssey USA, Inc.20174—
+3K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+3K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+3K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+3K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+3K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+3K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+3K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—