510(k) Report

Devices descending from K102807

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+4K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+4K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+4K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+4K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+4K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+4K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+4K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+4K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K203816DeGen Navigated InstrumentationDegen Medical20211—
+4K210472SPINEART Navigation Instrument SystemSpineart20215—
+4K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+4K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+4K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+4K202771CD Horizon Spinal SystemMedtronic202021—
+4K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+4K201006K2M Navigation InstrumentsK2m, Inc.20200—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K200303Reform Pedicle Screw SystemPrecision Spine202010—
+4K200070ARx Spinal SystemLife Spine, Inc.20209—
+4K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+4K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+4K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+4K191575ARx Spinal SystemLife Spine, Inc.201910—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+4K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+4K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+4K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+4K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+4K181188EVEREST Spinal SystemK2m, Inc.20186—
+4K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+4K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+4K172115Navigated Instrument SystemOrthofix, Inc.20184—
+4K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+4K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+4K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+4K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+4K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+4K170647Connector SystemOrthofix, Inc.201718—
+4K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+4K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+4K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+4K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+4K161842Overwatch Spine SystemAmendia, Inc.201661
+4K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+4K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+4K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+4K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+4K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+4K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+4K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+4K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+4K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201588—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+4K142360Everest Spinal SystemK2m, Inc.201522—
+4K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+4K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+4K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+4K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+5K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+5K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+5K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+5K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+5K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+5K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+5K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—