510(k) Report

Devices descending from K090064

701 later devices reach Eminent Spine Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+3K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+3K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+3K230329F3D Interbody SystemCorelink, LLC20230—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K222004INTEGRATE -C Interbody Fusion SystemHappe Spine20236—
+3K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+3K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+3K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+3K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+3K221844TDM Lumbar Interbody Fusion Cage SystemTdm Co., Ltd.20221—
+3K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+3K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+3K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K210573Velofix SA Cervical CageU&I Corporation20211—
+3K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+3K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+3K203444BEE HA CageNGMedical GmbH20211—
+3K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+3K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+3K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+3K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+3K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+3K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+3K183243Velofix TLIF CageU&I Corporation20190—
+3K190380nvcNvision Biomedical Technologies, Inc.20193—
+3K182477Cervical SpacerAdditive Implants, LLC201915—
+3K181829Velofix TLIF CageU&I Corporation20181—
+3K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+3K181397DualXInnovasive, Inc.201815—
+3K181337Sypher Spacer SystemBiogennix, LLC20180—
+3K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+3K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+3K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+3K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+3K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+3K172424Velofix™ SA Cervical CageU&I Corporation201751
+3K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+3K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+3K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+3K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+3K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+3K150481Cascadia Interbody SystemK2m, Inc.20154593
+3K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+3K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+3K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+3K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+3K140303Alamo TAlliance Partners, LLC20140—
+3K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+3K131671MectalifMedacta International201322—
+4K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+4K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+4K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+4K262094E3D™-C Interbody SystemEvolution Spine20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K260038E3D™-C Interbody SystemEvolution Spine20261—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+4K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+4K250560BEE HANGMedical GmbH20250—
+4K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K251016MectaLIF 3D MetalMedacta International S.A.20250—
+4K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+4K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+4K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+4K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+4K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+4K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+4K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+4K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+4K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+4K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+4K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+4K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+4K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+4K223326Axiom PSR SystemRestor3D202301
+4K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+4K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+4K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+4K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+4K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+4K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+4K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+4K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+4K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+4K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+4K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+4K212358Romero Cervical CageSpineup, Inc.20226—
+4K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—