510(k) Report

Devices descending from K091974

656 later devices reach Modification to CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+5K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+5K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+5K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+5K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+5K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+5K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+5K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+5K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+5K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+5K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+5K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+5K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+5K200896Solstice CCILife Spine, Inc.20200—
+5K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+5K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+5K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+5K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+5K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+5K191217Jazz PFImplanet, S.A.20190—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+5K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+5K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+5K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K172469TiLock Modular Spinal SystemGenesys Spine20170—
+5K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+5K171881JAZZ Passer BandImplanet, S.A.20170—
+5K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+5K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+5K170647Connector SystemOrthofix, Inc.201718—
+5K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+5K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+5K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+5K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+5K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+6K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+6K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K242042TriALTIS™ Spine SystemMedos International SARL20241—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K240526POWEReam Xia/SerratoStryker Instruments20240—
+6K232432E3D™-A Interbody SystemEvolution Spine20248—
+6K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+6K233366SYMPHONY OCT SystemMedos International SARL20230—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K230989Rod Registration FrameNu Vasive, Incorporated20230—
+6K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+6K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K222789VADER® Pedicle System, G21 CementIcotec AG202352
+6K223294SpineJack® Expansion KitStryker Instruments20221—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+6K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+6K222698CUVIS-spineCurexo, Inc.20220—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+6K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+6K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+6K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+6K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+6K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+6K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+6K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+6K182470Plateau Spacer SystemLife Spine20180—
+6K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+6K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+6K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+6K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+6K172194Connector SystemOrthofix, Inc.2017162
+6K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+7K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—