510(k) Report

Devices descending from K020152

1,684 later devices reach Synthes Vertebral Spacer TI through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+8K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+8K202032Idys LLIF 3DTiClariance, Sas20210—
+8K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+8K202380Born PT-LIF Cage HASpineworxx AG20210—
+8K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+8K200429BEE CagesNGMedical GmbH202111—
+8K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+8K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+8K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+8K200316UNiD IB3D ALIFMedicrea International SA20200—
+8K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+8K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+8K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+8K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+8K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+8K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+8K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+8K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+8K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+8K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+8K1920444CIS Marlin PEEK ACIF CageSolco Biomedical Co., Ltd.20190—
+8K191796Neo Cage SystemNeo Medical SA20190—
+8K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+8K190721LongBow TiLife Spine, Inc.20190—
+8K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+8K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+8K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+8K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+8K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+8K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+8K190488ProLift Expandable SystemLife Spine, Inc.201916—
+8K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+8K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+8K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+8K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+8K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+8K183259Idys™ TLIF TiVacClariance, Sas20191—
+8K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+8K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+8K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+8K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+8K181048Neo Cage System TMNeo Medical SA20191—
+8K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+8K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+8K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+8K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+8K182584Lucent® XPSpinal Elements, Inc.20183—
+8K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+8K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+8K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+8K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+8K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+8K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+8K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+8K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+8K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+8K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+8K172568CervagePrecifit Medical, Ltd.20181—
+8K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+8K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+8K173128Alamo® CAlliance Partners, LLC20182—
+8K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+8K172941CASCADIA Interbody SystemK2m201852—
+8K173508Everest Spinal SystemK2m20189—
+8K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+8K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+8K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+8K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+8K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+8K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+8K172083Idys™ ALIF SystemClariance, Sas20177—
+8K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+8K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+8K172065Scarlet AC-TSpineart20172—
+8K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+8K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+8K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+8K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+8K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+8K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+8K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+8K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+8K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+8K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+8K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+8K162496Foundation 3D InterbodyCorelink, LLC201782—
+8K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+8K163491NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017289—
+8K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+8K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+8K162587Roccia® AcifSilony Medical GmbH20171—
+8K162531Sterispine CCSafe Orthopaedics20160—
+8K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+8K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+8K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+8K161642CAVUX™ Cervical CageProvidence Medical Technology, Inc.20160—
+8K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+8K162264Cascadia Interbody SystemK2m, Inc.2016169—
+8K153665Prow Fusion-LNlt Spine, Ltd.20160—