510(k) Report

Devices descending from K031672

862 later devices reach Spinal Concepts, Inc. Infix System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+5K210359Hexanium TLIFSpinevision, S.A.S.20211—
+5K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+5K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+5K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+5K200429BEE CagesNGMedical GmbH202111—
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+5K202637F3D Corpectomy SystemCorelink, LLC20201—
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+5K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+5K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+5K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+5K200316UNiD IB3D ALIFMedicrea International SA20200—
+5K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+5K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+5K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+5K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+5K201585Monterey AL Interbody SystemStryker Corporation202044
+5K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+5K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+5K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+5K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+5K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+5K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+5K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+5K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+5K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+5K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+5K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+5K193521Steerable Plateau TiLife Spine, Inc.20201—
+5K192993Scarlet AL-TSpineart20201—
+5K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+5K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+5K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+5K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+5K1803473d CageFims Co., Ltd.20190—
+5K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+5K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+5K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+5K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+5K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+5K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+5K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+5K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+5K183092Kuros TLIF CageKuros Biosciences B.V20190—
+5K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+5K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+5K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+5K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+5K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+5K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+5K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+5K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+5K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+5K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+5K181397DualXInnovasive, Inc.201815—
+5K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+5K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+5K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+5K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+5K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+5K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+5K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+5K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+5K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+5K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+5K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+5K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+5K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+5K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+5K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+5K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+5K151654Prow FusionNlt Spine, Ltd.20151—
+5K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+5K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+5K140770MLX - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2014269—
+5K140162AP Expandable Xlif SystemNuvasive, Inc.2014236—
+6K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+6K261408SABER-XA SystemElevation Spine20260—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+6K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+6K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+6K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+6K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—