510(k) Report

Devices descending from K041722

1,150 later devices reach Modification to VBR Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+6K220902Navagio Lumbar CageKalitec Medical, LLC20220—
+6K220610SOLO-LAurora Spine, Inc.20220—
+6K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+6K220655X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20222—
+6K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+6K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+6K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+6K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+6K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+6K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+6K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+6K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+6K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+6K211413BEE PLIF CageNGMedical GmbH20211—
+6K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+6K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+6K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+6K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+6K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+6K203003Pantheon IBFDPantheon Spinal20210—
+6K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+6K211306LabyrinthZavation Medical Products, LLC20213—
+6K203802X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20213—
+6K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+6K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+6K200919Idys ALIF 3DTiClariance20210—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K202032Idys LLIF 3DTiClariance, Sas20210—
+6K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K200429BEE CagesNGMedical GmbH202111—
+6K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+6K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K202637F3D Corpectomy SystemCorelink, LLC20201—
+6K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+6K200316UNiD IB3D ALIFMedicrea International SA20200—
+6K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+6K201145X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20204—
+6K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+6K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+6K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+6K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+6K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+6K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+6K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+6K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+6K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+6K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+6K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+6K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+6K193258ProLift Expandable SystemLife Spine, Inc.20203—
+6K192993Scarlet AL-TSpineart20201—
+6K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+6K1803473d CageFims Co., Ltd.20190—
+6K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+6K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+6K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+6K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K183064TxTi IBF SystemInnovasis, Inc.2019481
+6K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+6K191263Idys ALIF TiVacClariance, Sas20190—
+6K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+6K182349Concorde LiftMedos International SARL20190—
+6K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+6K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+6K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+6K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+6K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+6K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+6K182470Plateau Spacer SystemLife Spine20180—
+6K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+6K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+6K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+6K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+6K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+6K180431Cortina [MAX] Lumbar Cage SystemNeurostructures, Inc.20181—
+6K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+6K173537Concorde Lift™Medos International SARL20181—
+6K172816TiGer Shark™ SystemChoicespine, LP201859—
+6K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+6K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+6K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+6K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+6K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+6K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+6K171519FLXfit™Expanding Orthopedics, Inc.2017711
+6K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+6K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+6K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+6K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+6K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+6K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+6K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+6K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+6K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+6K162262Tritanium® PL CageStryker2016132—
+6K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+6K160856SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.20165—