510(k) Report

Devices descending from K024364

1,683 later devices reach Synthes Vertebral Spacer TI (Curved and Narrow) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K211740DualXAmplify Surgical, Inc.20211—
+7K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+7K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+7K211413BEE PLIF CageNGMedical GmbH20211—
+7K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+7K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+7K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+7K202032Idys LLIF 3DTiClariance, Sas20210—
+7K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+7K210359Hexanium TLIFSpinevision, S.A.S.20211—
+7K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+7K202380Born PT-LIF Cage HASpineworxx AG20210—
+7K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+7K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+7K200429BEE CagesNGMedical GmbH202111—
+7K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+7K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+7K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+7K200316UNiD IB3D ALIFMedicrea International SA20200—
+7K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+7K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+7K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+7K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+7K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+7K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+7K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+7K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+7K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+7K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+7K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+7K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+7K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+7K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+7K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+7K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+7K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+7K191796Neo Cage SystemNeo Medical SA20190—
+7K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+7K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+7K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+7K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+7K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+7K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+7K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+7K190488ProLift Expandable SystemLife Spine, Inc.201916—
+7K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+7K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+7K183243Velofix TLIF CageU&I Corporation20190—
+7K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+7K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+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—
+7K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+7K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+7K183259Idys™ TLIF TiVacClariance, Sas20191—
+7K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+7K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+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—
+7K182584Lucent® XPSpinal Elements, Inc.20183—
+7K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+7K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+7K181829Velofix TLIF CageU&I Corporation20181—
+7K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+7K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+7K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+7K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+7K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+7K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+7K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+7K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+7K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+7K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+7K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+7K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+7K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+7K172568CervagePrecifit Medical, Ltd.20181—
+7K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+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—
+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—
+7K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+7K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+7K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+7K172083Idys™ ALIF SystemClariance, Sas20177—
+7K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+7K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+7K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+7K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+7K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—