510(k) Report

Devices descending from K991031

878 later devices reach Colorado II Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+7K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+7K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+7K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+7K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+7K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+7K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+7K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+7K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+7K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+7K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+7K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+7K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+7K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+7K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+7K200896Solstice CCILife Spine, Inc.20200—
+7K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+7K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+7K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+7K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K191217Jazz PFImplanet, S.A.20190—
+7K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+7K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+7K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+7K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+7K182182YUKON OCT Spinal SystemK2m20185—
+7K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+7K181188EVEREST Spinal SystemK2m, Inc.20186—
+7K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+7K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+7K171881JAZZ Passer BandImplanet, S.A.20170—
+7K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+7K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+7K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+7K170647Connector SystemOrthofix, Inc.201718—
+7K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+7K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+7K151977icotec Pedicle SystemIcotec AG201630—
+7K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+7K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+7K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+7K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+7K131250Tiger Spine SystemCorelink, LLC201340—
+7K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+7K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+8K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+8K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+8K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K242042TriALTIS™ Spine SystemMedos International SARL20241—
+8K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+8K240526POWEReam Xia/SerratoStryker Instruments20240—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K233366SYMPHONY OCT SystemMedos International SARL20230—
+8K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+8K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+8K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+8K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+8K230989Rod Registration FrameNu Vasive, Incorporated20230—
+8K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+8K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+8K222789VADER® Pedicle System, G21 CementIcotec AG202352
+8K223294SpineJack® Expansion KitStryker Instruments20221—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+8K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+8K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+8K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+8K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+8K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+8K203023Pisces Spinal SystemOrtho Development Corporation20210—
+8K211306LabyrinthZavation Medical Products, LLC20213—
+8K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+8K202476Salvo® Spine SystemSpine Wave, Inc.20204—