510(k) Report

Devices descending from K081917

1,008 later devices reach Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K223251Hexanium PLIFSpinevision, S.A.S.20220—
+5K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+5K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+5K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+5K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+5K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+5K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+5K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+5K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+5K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+5K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+5K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+5K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+5K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+5K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+5K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+5K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+5K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+5K211413BEE PLIF CageNGMedical GmbH20211—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+5K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+5K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+5K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+5K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+5K203003Pantheon IBFDPantheon Spinal20210—
+5K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+5K211306LabyrinthZavation Medical Products, LLC20213—
+5K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+5K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+5K201671A-Link ZAcuity Surgical Devices, LLC202125—
+5K200919Idys ALIF 3DTiClariance20210—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K202032Idys LLIF 3DTiClariance, Sas20210—
+5K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+5K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+5K200429BEE CagesNGMedical GmbH202111—
+5K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+5K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+5K202637F3D Corpectomy SystemCorelink, LLC20201—
+5K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+5K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+5K200316UNiD IB3D ALIFMedicrea International SA20200—
+5K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+5K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+5K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+5K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+5K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+5K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+5K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+5K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+5K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+5K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+5K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+5K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+5K193521Steerable Plateau TiLife Spine, Inc.20201—
+5K193258ProLift Expandable SystemLife Spine, Inc.20203—
+5K192993Scarlet AL-TSpineart20201—
+5K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+5K1803473d CageFims Co., Ltd.20190—
+5K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+5K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+5K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+5K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+5K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+5K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+5K190885Elevation Spine Saber-C SystemElevation Spine201925—
+5K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+5K183064TxTi IBF SystemInnovasis, Inc.2019481
+5K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+5K191263Idys ALIF TiVacClariance, Sas20190—
+5K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+5K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+5K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+5K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+5K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+5K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+5K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+5K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+5K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+5K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+5K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+5K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+5K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+5K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+5K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+5K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+5K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+5K172816TiGer Shark™ SystemChoicespine, LP201859—