510(k) Report

Devices descending from K981676

1,218 later devices reach CD Horizon Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+5K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+5K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+5K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+5K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+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—
+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—
+5K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+5K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+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—
+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—
+5K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+5K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+5K202624Z-Span Plate SystemZavation Medical Products, LLC20201—
+5K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+5K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+5K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+5K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+5K201006K2M Navigation InstrumentsK2m, Inc.20200—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K200896Solstice CCILife Spine, Inc.20200—
+5K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+5K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+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—
+5K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+5K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+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—
+5K190751Connector SystemOrthofix, Inc.20193—
+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—
+5K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+5K182240PASS LP Spinal SystemMedicrea International SA20182—
+5K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+5K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+5K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+5K180166Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc.20189—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+5K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+5K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+5K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+5K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+5K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+5K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+5K171582NEO Pedicle Screw System™Neo Medical SA20170—
+5K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+5K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+5K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+5K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+5K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+5K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+5K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+5K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+5K162824Z-Span Plate SystemZavation, LLC20172—
+5K162786PASS LP Spinal SystemMedicrea International SA20176—
+5K162764Jazz Frame SystemImplanet, S.A.20176—
+5K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+5K161379ELSA SpacersGlobus Medical, Inc.2016155—
+5K162143FixxSure® X-LinkInnovasis, Inc.20160—
+5K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+5K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+5K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+5K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—