510(k) Report

Devices descending from K003275

1,705 later devices reach Synthes Synmesh Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+7K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+7K200919Idys ALIF 3DTiClariance20210—
+7K202032Idys LLIF 3DTiClariance, Sas20210—
+7K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+7K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+7K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+7K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+7K202380Born PT-LIF Cage HASpineworxx AG20210—
+7K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+7K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+7K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+7K200429BEE CagesNGMedical GmbH202111—
+7K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+7K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+7K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+7K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+7K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+7K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+7K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+7K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+7K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+7K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+7K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+7K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+7K200312Tryptik TiSpineart20202—
+7K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+7K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+7K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+7K191796Neo Cage SystemNeo Medical SA20190—
+7K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+7K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+7K191134IB3D AlifMedicrea International SA20191—
+7K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+7K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+7K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+7K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+7K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+7K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+7K190488ProLift Expandable SystemLife Spine, Inc.201916—
+7K190680Favo S-TlifSilony Medical GmbH20190—
+7K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+7K183243Velofix TLIF CageU&I Corporation20190—
+7K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+7K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+7K191263Idys ALIF TiVacClariance, Sas20190—
+7K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+7K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+7K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+7K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+7K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+7K183259Idys™ TLIF TiVacClariance, Sas20191—
+7K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+7K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+7K181048Neo Cage System TMNeo Medical SA20191—
+7K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+7K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+7K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+7K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+7K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+7K182584Lucent® XPSpinal Elements, Inc.20183—
+7K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+7K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+7K181963ostaPek Interbody Fusion CagesColigne AG20181—
+7K181829Velofix TLIF CageU&I Corporation20181—
+7K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+7K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+7K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+7K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+7K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+7K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+7K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+7K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+7K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+7K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+7K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+7K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+7K172568CervagePrecifit Medical, Ltd.20181—
+7K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+7K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+7K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+7K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+7K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+7K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+7K172941CASCADIA Interbody SystemK2m201852—
+7K173508Everest Spinal SystemK2m20189—
+7K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+7K173702Juliet Ti LLSpineart20182—
+7K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+7K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+7K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+7K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+7K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+7K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+7K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+7K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+7K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+7K172065Scarlet AC-TSpineart20172—
+7K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—