510(k) Report

Devices descending from K033926

763 later devices reach Hourglass Vertebral Body Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+6K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+6K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+6K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNu Vasive, Incorporated20223—
+6K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+6K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+6K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+6K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+6K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+6K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+6K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+6K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+6K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+6K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+6K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+6K211740DualXAmplify Surgical, Inc.20211—
+6K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+6K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+6K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+6K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+6K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+6K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+6K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+6K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+6K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+6K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+6K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+6K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+6K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+6K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+6K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+6K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+6K192897icotec Cervical CageIcotec AG20201—
+6K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+6K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+6K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+6K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+6K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+6K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+6K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+6K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+6K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+6K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+6K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+6K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+6K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+6K183243Velofix TLIF CageU&I Corporation20190—
+6K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+6K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+6K182477Cervical SpacerAdditive Implants, LLC201915—
+6K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+6K181829Velofix TLIF CageU&I Corporation20181—
+6K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+6K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+6K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+6K181014Tritanium PL CageStryker Spine2018137—
+6K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+6K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+6K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+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—
+6K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+6K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+6K171312FortiCore®Nanovis, LLC20183—
+6K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+6K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+6K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+6K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+6K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+6K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+6K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+6K171140Matrixx SystemNexxt Spine, LLC2017145—
+6K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+6K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+6K170055CAPRI Corpectomy Cage SystemK2m201711—
+6K163364MOJAVE Expandable Interbody SystemK2m201725—
+6K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+6K162264Cascadia Interbody SystemK2m, Inc.2016169—
+6K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+7K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+7K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+7K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—