510(k) Report

Devices descending from K042930

1,440 later devices reach Spacevision Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+7K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+7K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+7K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+7K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+7K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+7K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+7K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+7K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+7K221244CD Horizon™ Spinal SystemMedtronic202220—
+7K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+7K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+7K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+7K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+7K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+7K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+7K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+7K201793EDEN Peek CageJmt Co., Ltd.20210—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+7K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+7K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+7K211306LabyrinthZavation Medical Products, LLC20213—
+7K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+7K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+7K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+7K203444BEE HA CageNGMedical GmbH20211—
+7K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+7K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+7K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+7K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+7K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+7K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+7K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+7K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+7K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+7K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+7K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+7K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+7K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+7K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+7K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+7K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+7K201087CORBEL SpacersGlobus Medical, Inc.202036—
+7K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+7K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+7K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+7K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+7K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+7K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+7K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+7K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+7K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+7K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+7K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+7K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+7K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+7K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+7K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+7K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+7K190488ProLift Expandable SystemLife Spine, Inc.201916—
+7K190680Favo S-TlifSilony Medical GmbH20190—
+7K182608Oyster ACIF CageSilony Medical GmbH20190—
+7K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+7K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+7K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+7K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+7K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+7K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+7K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+7K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+7K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+7K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+7K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+7K181963ostaPek Interbody Fusion CagesColigne AG20181—
+7K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+7K181397DualXInnovasive, Inc.201815—
+7K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+7K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+7K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+7K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+7K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+7K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+7K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+7K172568CervagePrecifit Medical, Ltd.20181—
+7K173128Alamo® CAlliance Partners, LLC20182—
+7K172115Navigated Instrument SystemOrthofix, Inc.20184—
+7K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+7K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+7K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+7K173508Everest Spinal SystemK2m20189—
+7K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+7K170235Lucent®Spinal Elements, Inc.2017107—
+7K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+7K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+7K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—