510(k) Report

Devices descending from K031914

1,530 later devices reach Spinal Concepts, Inc. Cadence and Fortitude through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K212562Idys-C ZP 3DTiClariance, SA20211—
+8K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+8K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+8K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+8K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+8K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+8K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+8K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+8K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+8K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+8K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+8K203444BEE HA CageNGMedical GmbH20211—
+8K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+8K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+8K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+8K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+8K200429BEE CagesNGMedical GmbH202111—
+8K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+8K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+8K202637F3D Corpectomy SystemCorelink, LLC20201—
+8K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+8K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+8K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+8K200316UNiD IB3D ALIFMedicrea International SA20200—
+8K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+8K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+8K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+8K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+8K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+8K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+8K201087CORBEL SpacersGlobus Medical, Inc.202036—
+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
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+8K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+8K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+8K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+8K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+8K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+8K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+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—
+8K192897icotec Cervical CageIcotec AG20201—
+8K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+8K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+8K190284Bengal Stackable Cage SystemMedos International SARL20190—
+8K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+8K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+8K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+8K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+8K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+8K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+8K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+8K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+8K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+8K190885Elevation Spine Saber-C SystemElevation Spine201925—
+8K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+8K190488ProLift Expandable SystemLife Spine, Inc.201916—
+8K190680Favo S-TlifSilony Medical GmbH20190—
+8K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+8K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+8K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+8K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+8K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+8K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+8K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+8K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+8K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+8K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+8K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+8K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+8K180909REVEL SpacersGlobus Medical, Inc.201837—
+8K181397DualXInnovasive, Inc.201815—
+8K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+8K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+8K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+8K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+8K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+8K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+8K172568CervagePrecifit Medical, Ltd.20181—
+8K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+8K173128Alamo® CAlliance Partners, LLC20182—
+8K172115Navigated Instrument SystemOrthofix, Inc.20184—
+8K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+8K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+8K173508Everest Spinal SystemK2m20189—
+8K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+8K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+8K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+8K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+8K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+8K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+8K162496Foundation 3D InterbodyCorelink, LLC201782—
+8K162921Navigated Instrument SystemOrthofix, Inc.20175—
+8K163180Hubble IIOrbbo Surgical, LLC20160—
+8K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+8K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+8K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—