510(k) Report

Devices descending from K003155

2,091 later devices reach Vertebral Body Replacement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+9K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+9K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+9K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+9K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+9K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+9K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+9K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+9K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+9K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+9K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+9K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+9K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+9K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+9K203003Pantheon IBFDPantheon Spinal20210—
+9K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+9K201569CUVIS-spineCurexo, Inc.20212—
+9K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+9K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+9K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+9K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+9K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+9K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+9K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+9K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+9K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+9K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+9K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+9K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+9K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+9K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+9K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+9K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+9K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+9K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+9K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+9K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+9K200896Solstice CCILife Spine, Inc.20200—
+9K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+9K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+9K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+9K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+9K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+9K191217Jazz PFImplanet, S.A.20190—
+9K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+9K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+9K182608Oyster ACIF CageSilony Medical GmbH20190—
+9K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+9K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+9K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+9K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+9K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+9K182584Lucent® XPSpinal Elements, Inc.20183—
+9K182182YUKON OCT Spinal SystemK2m20185—
+9K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+9K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+9K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+9K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+9K181188EVEREST Spinal SystemK2m, Inc.20186—
+9K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+9K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+9K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+9K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+9K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+9K171519FLXfit™Expanding Orthopedics, Inc.2017711
+9K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+9K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+9K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+9K171881JAZZ Passer BandImplanet, S.A.20170—
+9K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+9K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+9K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+9K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+9K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+9K170647Connector SystemOrthofix, Inc.201718—
+9K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+9K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+9K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+9K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+9K162575Z-LINKPC SystemZavation, LLC20173—
+9K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+9K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+9K162262Tritanium® PL CageStryker2016132—
+9K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+9K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+9K160955Tritanium® PL CageStryker2016178—
+9K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+9K160715AccuLIF TL and PL CageStryker Corporation20160—
+9K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+9K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+9K150918PASS OCT Spinal SystemMedicrea International SA201513—
+9K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+9K150152The Octane Straight Intervertebral Fusion Device, Ti CoatedExactech, Inc.201510—
+9K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+9K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+9K141284Caspian Spinal SystemK2m, Inc.20140—
+9K141217Acculif TL and PL CageStryker Corporation20146423
+9K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—