510(k) Report

Devices descending from K043343

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K233300POWEReam 1/4 DriveStryker Instruments20231—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+6K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+6K233366SYMPHONY OCT SystemMedos International SARL20230—
+6K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+6K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K231479TriALTIS Spine SystemMedos International SARL20238—
+6K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+6K221307Edge Upper Cervical SystemSpinal Simplicity, LLC20230—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+6K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+6K223558CUVIS-spineCurexo, Inc.20230—
+6K230614Cortium™Ulrich Medical USA20230—
+6K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+6K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+6K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K213918DeGen Navigated InstrumentationDegen Medical20220—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+6K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+6K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+6K211323ASTRA Spine SystemSpinecraft, LLC202112—
+6K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+6K201569CUVIS-spineCurexo, Inc.20212—
+6K210306GII Spinal Fixation SystemColigne AG20210—
+6K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+6K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+6K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+6K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+6K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+6K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+6K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+6K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+6K200303Reform Pedicle Screw SystemPrecision Spine202010—
+6K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+6K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+6K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+6K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+6K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+6K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+6K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+6K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+6K182182YUKON OCT Spinal SystemK2m20185—
+6K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+6K182240PASS LP Spinal SystemMedicrea International SA20182—
+6K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+6K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+6K172115Navigated Instrument SystemOrthofix, Inc.20184—
+6K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+6K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+6K173126Arisstos™ Spinal SystemIngenium Spine20171—
+6K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+6K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+6K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+6K170647Connector SystemOrthofix, Inc.201718—
+6K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+6K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+6K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+6K162575Z-LINKPC SystemZavation, LLC20173—
+6K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+6K161842Overwatch Spine SystemAmendia, Inc.201661
+6K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+6K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+6K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+6K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+6K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+6K151974Polaris Spinal SystemBiomet Spine201516—
+6K150918PASS OCT Spinal SystemMedicrea International SA201513—
+6K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+6K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+6K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961