510(k) Report

Devices descending from K040583

1,161 later devices reach Modification to: CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+5K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K222415Rexious Spinal Fixation SystemDio Medical Corporation20221—
+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—
+5K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+5K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+5K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+5K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+5K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+5K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+5K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+5K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+5K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+5K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+5K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+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—
+5K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, 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—
+5K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+5K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+5K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+5K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+5K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+5K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+5K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+5K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+5K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+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—
+5K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+5K200896Solstice CCILife Spine, Inc.20200—
+5K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+5K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+5K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+5K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+5K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+5K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+5K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+5K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+5K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+5K193219G Surgical Marksman SystemG Surgical, LLC20191—
+5K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+5K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+5K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+5K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+5K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+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—
+5K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K181397DualXInnovasive, Inc.201815—
+5K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+5K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+5K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+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—