510(k) Report

Devices descending from K042268

1,620 later devices reach Ebi Cas Spine Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+7K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+7K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+7K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+7K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+7K201793EDEN Peek CageJmt Co., Ltd.20210—
+7K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+7K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+7K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+7K203003Pantheon IBFDPantheon Spinal20210—
+7K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+7K210728CONDUIT InstrumentsMedos International SARL20215—
+7K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+7K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+7K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+7K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+7K202637F3D Corpectomy SystemCorelink, LLC20201—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K200316UNiD IB3D ALIFMedicrea International SA20200—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.20206—
+7K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+7K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+7K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+7K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+7K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+7K192993Scarlet AL-TSpineart20201—
+7K193174Keos Lumbar IBFDKeos20190—
+7K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+7K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+7K192117Small VBR™Ulrich GmbH & Co. KG20196—
+7K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+7K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+7K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+7K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+7K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+7K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+7K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+7K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+7K182721Choice Spine Navigation SystemChoicespine, LP20192—
+7K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+7K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+7K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+7K181188EVEREST Spinal SystemK2m, Inc.20186—
+7K180437Hexanium® TLIFSpinevision, S.A.S.20182—
+7K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+7K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+7K173025NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System; NuVasive® AP…Nu Vasive, Incorporated20188—
+7K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+7K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+7K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+7K171321K2M Navigation InstrumentsK2m201711
+7K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+7K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+7K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc.2017224—
+7K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+7K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+7K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+7K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+7K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+7K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+7K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+7K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+7K151406Cogent Lateral Interbody SystemCogent Spine, LLC201611—
+7K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+7K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+7K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+7K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+7K152651AccuLIF TL and PL CageStryker Corporation201530—
+7K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+7K152304Tritanium PL CageStryker20154481
+7K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+7K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+7K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+7K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp.20145—
+7K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+7K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+7K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+7K142193Cogent Med-Lif XLCogent Spine, LLC201412—
+7K1421124WEB Spinal Implant Products4Web, Inc.201433—
+7K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+7K130445Vault Alif SystemSpinal USA20139—
+7K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+7K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+7K111835Plateau Spacer SystemLife Spine, Inc.2011120—
+7K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+8K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+8K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—