510(k) Report

Devices descending from K001066

768 later devices reach CD Horizon Eclipse through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+6K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+6K200281The Gecko Spinal SystemOrtho Development Corporation20200—
+6K200097Response BandLoc Spinal FixationOrthoPediatrics Corp.20200—
+6K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+6K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+6K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+6K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+6K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+6K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+6K190567KeYi Spinal Fixation SystemBeijing Keyi Medical Device Technology Co., Ltd.20190—
+6K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+6K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+6K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+6K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+6K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+6K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+6K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+6K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+6K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+6K182240PASS LP Spinal SystemMedicrea International SA20182—
+6K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+6K181799ResCUBE™ Ligament Fixation SystemCousin Biotech Sas20180—
+6K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+6K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811
+6K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+6K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+6K172115Navigated Instrument SystemOrthofix, Inc.20184—
+6K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+6K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+6K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+6K173126Arisstos™ Spinal SystemIngenium Spine20171—
+6K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+6K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+6K172194Connector SystemOrthofix, Inc.2017162
+6K171881JAZZ Passer BandImplanet, S.A.20170—
+6K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+6K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+6K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+6K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+6K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+6K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG201671
+6K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+6K161016Z-Clamp ISP SystemZavation, LLC20160—
+6K161842Overwatch Spine SystemAmendia, Inc.201661
+6K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+6K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+6K160698LigaPASSMedicrea International SA201612—
+6K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+6K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+6K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+6K161265NuVasive® VersaTie SystemNu Vasive, Incorporated20163—
+6K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+6K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+6K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+6K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20160—
+6K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+6K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+6K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+6K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+6K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+6K151740JAZZ SystemImplanet, S.A.201512—
+6K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC20158—
+6K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+6K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+6K143759JAZZ SystemImplanet, S.A.201513—
+6K142217Reliance Interspinous Plate SystemReliance Medical Systems, LLC20150—
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K142378Interspinous Plate SystemPrecision Spine, Inc.20143—
+6K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+6K140734Nextgen Altius Oct SystemEbi, LLC20140—
+6K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+6K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc.2014272
+6K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+6K133617Jazz SystemImplanet, S.A.201414—
+6K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+6K132968Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine201312—
+6K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+6K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+6K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+6K123138Pass LP Spinal SystemMedicrea International2013132—
+6K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)201271
+6K120571Synthes Uss ConnectorSynthes Spine201274—
+6K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+6K113346Neon SystemUlrich GmbH & Co. KG20121—
+6K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—