510(k) Report

Devices descending from K082128

933 later devices reach Depuy Spine Lateral Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+6K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+6K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+6K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+6K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+6K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+6K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+6K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+6K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+6K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+6K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+6K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+6K211413BEE PLIF CageNGMedical GmbH20211—
+6K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+6K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+6K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+6K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+6K211306LabyrinthZavation Medical Products, LLC20213—
+6K203802X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20213—
+6K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+6K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+6K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+6K200429BEE CagesNGMedical GmbH202111—
+6K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+6K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+6K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+6K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+6K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+6K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+6K200316UNiD IB3D ALIFMedicrea International SA20200—
+6K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+6K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+6K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+6K201820NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated2020156—
+6K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+6K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+6K201145X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20204—
+6K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+6K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+6K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+6K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+6K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+6K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+6K193258ProLift Expandable SystemLife Spine, Inc.20203—
+6K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+6K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+6K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+6K191796Neo Cage SystemNeo Medical SA20190—
+6K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+6K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+6K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+6K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+6K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+6K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+6K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+6K182349Concorde LiftMedos International SARL20190—
+6K183092Kuros TLIF CageKuros Biosciences B.V20190—
+6K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+6K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+6K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+6K181048Neo Cage System TMNeo Medical SA20191—
+6K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+6K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+6K182470Plateau Spacer SystemLife Spine20180—
+6K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+6K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+6K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+6K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+6K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+6K180695FBC 921 (Alif)Fbc Device Aps20180—
+6K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+6K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+6K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+6K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+6K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+6K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+6K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+6K173537Concorde Lift™Medos International SARL20181—
+6K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+6K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+6K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+6K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+6K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+6K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+6K171519FLXfit™Expanding Orthopedics, Inc.2017711
+6K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+6K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+6K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+6K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+6K162496Foundation 3D InterbodyCorelink, LLC201782—
+6K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+6K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+6K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+6K162262Tritanium® PL CageStryker2016132—
+6K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+6K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+6K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—