510(k) Report

Devices descending from K033517

1,528 later devices reach Spinal Concepts Inc. Cadence and Traxis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+7K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+7K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+7K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+7K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+7K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+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—
+7K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+7K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+7K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+7K200429BEE CagesNGMedical GmbH202111—
+7K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+7K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+7K202637F3D Corpectomy SystemCorelink, LLC20201—
+7K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+7K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+7K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+7K200316UNiD IB3D ALIFMedicrea International SA20200—
+7K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+7K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+7K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+7K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+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
+7K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+7K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+7K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+7K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+7K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+7K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+7K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+7K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+7K192897icotec Cervical CageIcotec AG20201—
+7K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+7K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+7K190284Bengal Stackable Cage SystemMedos International SARL20190—
+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—
+7K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+7K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+7K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+7K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+7K190885Elevation Spine Saber-C SystemElevation Spine201925—
+7K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+7K190488ProLift Expandable SystemLife Spine, Inc.201916—
+7K190680Favo S-TlifSilony Medical GmbH20190—
+7K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+7K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+7K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+7K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+7K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+7K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+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—
+7K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+7K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+7K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+7K180909REVEL SpacersGlobus Medical, Inc.201837—
+7K181397DualXInnovasive, Inc.201815—
+7K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+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—
+7K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+7K173128Alamo® CAlliance Partners, LLC20182—
+7K172115Navigated Instrument SystemOrthofix, Inc.20184—
+7K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+7K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+7K173508Everest Spinal SystemK2m20189—
+7K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+7K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+7K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+7K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+7K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+7K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+7K162496Foundation 3D InterbodyCorelink, LLC201782—
+7K162921Navigated Instrument SystemOrthofix, Inc.20175—
+7K163180Hubble IIOrbbo Surgical, LLC20160—
+7K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+7K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+7K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+7K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+7K160958Battalion Universal Spacer SystemAlphatec Spine2016114—