510(k) Report

Devices descending from K001255

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+7K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+7K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+7K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+7K213918DeGen Navigated InstrumentationDegen Medical20220—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+7K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+7K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+7K211323ASTRA Spine SystemSpinecraft, LLC202112—
+7K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+7K201569CUVIS-spineCurexo, Inc.20212—
+7K210306GII Spinal Fixation SystemColigne AG20210—
+7K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+7K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+7K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+7K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+7K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K200303Reform Pedicle Screw SystemPrecision Spine202010—
+7K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+7K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+7K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+7K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+7K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+7K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+7K182182YUKON OCT Spinal SystemK2m20185—
+7K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+7K181188EVEREST Spinal SystemK2m, Inc.20186—
+7K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+7K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+7K172115Navigated Instrument SystemOrthofix, Inc.20184—
+7K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+7K173126Arisstos™ Spinal SystemIngenium Spine20171—
+7K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+7K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+7K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+7K170647Connector SystemOrthofix, Inc.201718—
+7K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+7K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+7K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+7K162575Z-LINKPC SystemZavation, LLC20173—
+7K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+7K161842Overwatch Spine SystemAmendia, Inc.201661
+7K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+7K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+7K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+7K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+7K151974Polaris Spinal SystemBiomet Spine201516—
+7K150918PASS OCT Spinal SystemMedicrea International SA201513—
+7K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+7K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+7K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+7K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+7K150390Nautilus Spinal SystemLife Spine, Inc.20150—
+7K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+7K142360Everest Spinal SystemK2m, Inc.201522—
+7K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+7K141284Caspian Spinal SystemK2m, Inc.20140—
+7K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+7K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+7K131833Centurion Poct SystemOrthofix, Inc.20142—
+7K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+7K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+7K120998Solstice Cross ConnectorLife Spine20121—
+8K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+8K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+8K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+8K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+8K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+8K252322SIros-X SystemGenesys Spine20250—
+8K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+8K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243693NEO Pedicle Screw System™Neo Medical SA20240—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—