510(k) Report

Devices descending from K011508

714 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+8K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+8K201569CUVIS-spineCurexo, Inc.20212—
+8K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+8K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+8K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+8K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+8K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+8K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+8K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+8K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+8K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+8K200896Solstice CCILife Spine, Inc.20200—
+8K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+8K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+8K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+8K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+8K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+8K191217Jazz PFImplanet, S.A.20190—
+8K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+8K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+8K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+8K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+8K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+8K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+8K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+8K172469TiLock Modular Spinal SystemGenesys Spine20170—
+8K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+8K171881JAZZ Passer BandImplanet, S.A.20170—
+8K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+8K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+8K170647Connector SystemOrthofix, Inc.201718—
+8K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+8K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+8K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+8K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+8K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+9K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+9K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+9K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+9K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+9K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+9K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+9K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+9K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+9K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+9K242042TriALTIS™ Spine SystemMedos International SARL20241—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+9K233256Robotic Integration InstrumentsDePuy Synthes20240—
+9K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+9K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+9K233366SYMPHONY OCT SystemMedos International SARL20230—
+9K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+9K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+9K230989Rod Registration FrameNu Vasive, Incorporated20230—
+9K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+9K222789VADER® Pedicle System, G21 CementIcotec AG202352
+9K223294SpineJack® Expansion KitStryker Instruments20221—
+9K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+9K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+9K222698CUVIS-spineCurexo, Inc.20220—
+9K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+9K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+9K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+9K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+9K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+9K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+9K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+9K182470Plateau Spacer SystemLife Spine20180—
+9K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+9K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+9K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+9K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+9K172194Connector SystemOrthofix, Inc.2017162
+9K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+10K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+10K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+10K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+10K250637VCFix Spinal SystemAmber Implants20250—
+10K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+10K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+10K234035COSINE™ SpacerGlobus Medical, Inc.20240—