510(k) Report

Devices descending from K011406

2,048 later devices reach Spinal Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC20222—
+8K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA20221—
+8K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+8K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+8K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+8K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+8K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+8K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+8K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+8K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+8K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+8K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+8K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+8K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+8K203003Pantheon IBFDPantheon Spinal20210—
+8K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+8K201569CUVIS-spineCurexo, Inc.20212—
+8K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+8K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+8K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+8K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+8K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+8K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+8K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+8K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+8K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+8K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+8K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+8K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+8K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+8K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+8K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+8K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+8K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+8K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+8K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+8K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+8K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+8K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+8K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+8K200896Solstice CCILife Spine, Inc.20200—
+8K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+8K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+8K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+8K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+8K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+8K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+8K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+8K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+8K191778Omnia Medical VBROmnia Medical, LLC20195—
+8K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+8K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+8K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+8K191217Jazz PFImplanet, S.A.20190—
+8K190680Favo S-TlifSilony Medical GmbH20190—
+8K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+8K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+8K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+8K182608Oyster ACIF CageSilony Medical GmbH20190—
+8K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+8K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+8K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+8K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+8K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+8K182584Lucent® XPSpinal Elements, Inc.20183—
+8K182182YUKON OCT Spinal SystemK2m20185—
+8K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+8K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+8K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+8K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+8K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+8K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+8K181188EVEREST Spinal SystemK2m, Inc.20186—
+8K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+8K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+8K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+8K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+8K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+8K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+8K171519FLXfit™Expanding Orthopedics, Inc.2017711
+8K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+8K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+8K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+8K171881JAZZ Passer BandImplanet, S.A.20170—
+8K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+8K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+8K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+8K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+8K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+8K170647Connector SystemOrthofix, Inc.201718—
+8K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+8K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+8K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+8K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+8K162575Z-LINKPC SystemZavation, LLC20173—
+8K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—