510(k) Report

Devices descending from K034056

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K233684TriALTIS™ Spine SystemMedos International SARL20234—
+5K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+5K231658VEOS Spinal Fixation SystemSpineway20230—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+5K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+5K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+5K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+5K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+5K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+5K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+5K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+5K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+5K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+5K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+5K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+5K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+5K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+5K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+5K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+5K203816DeGen Navigated InstrumentationDegen Medical20211—
+5K210472SPINEART Navigation Instrument SystemSpineart20215—
+5K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+5K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+5K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+5K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+5K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+5K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+5K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+5K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+5K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+5K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+5K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+5K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+5K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+5K190567KeYi Spinal Fixation SystemBeijing Keyi Medical Device Technology Co., Ltd.20190—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+5K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+5K181995Chiral Surgical Pedicle Screw SystemChiral Surgical20180—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+5K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+5K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+5K180433Ennovate®Aesculap Implant Systems, LLC201811
+5K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+5K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+5K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—