510(k) Report

Devices descending from K032037

79 later devices reach CD Horizon (Addition of Spinous Process Plate) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141508Romeo 2 Pad Posterior Axial DeviceSpineart20141—
+1K132765PFX Spinous Process Fixation SystemInnovasis, Inc.20140—
+1K132191SP-Fix Spinous Process Fixation PlateGlobus Medical, Inc.20136—
+1K121924Integra Interspinous Process SystemSeaspine, Inc.20131—
+1K123232Spineology Spinous Process PlateSpineology, Inc.20131—
+1K123093Stabilink Mis Spinal Fixation SystemSouthern Spine, LLC20126—
+1K122509Vertiflex Spinous Process Fixation PlateVertiflex, Inc.201218—
+1K113157Aileron Interspinous Fixation SystemLife Spine20121—
+1K102195SP-Fix Spinous Process Fixation PlateGlobus Medical, Inc.201132—
+1K093438Paradigm Interspinous Fusion PlateParadigm Spine, LLC201051
+1K092325Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20093—
+1K043053Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek200576—
+2K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+2K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+2K173334SeaSpine Spinous Process SystemSeaSpine Orthopedics Corporation20180—
+2K161016Z-Clamp ISP SystemZavation, LLC20160—
+2K153302coflex-IFParadigm Spine, LLC20162—
+2K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20160—
+2K143631Benefix Interspinous Fixation SystemU&I Corporation20150—
+2K142217Reliance Interspinous Plate SystemReliance Medical Systems, LLC20150—
+2K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC20159—
+2K142378Interspinous Plate SystemPrecision Spine, Inc.20143—
+2K140236Aileron Interspinous Fixation SystemLife Spine, Inc.20140—
+2K142213Via Spinous Process Fixation SystemSpineology, Inc.20140—
+2K133363Interbridge Interspinous Posterior Fixation SystemLdr Spine USA, Inc.20145—
+2K132968Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine201312—
+2K123246CD Horizon Spire Z Spinal SystemMedtronic Sofamor Danek20122—
+2K121316Lanx Spinal Fization SystemLanx, Inc.20123—
+2K112595Coflex-FParadigm Spine, LLC20124—
+2K100354Primal OK Interspinous Fusion SystemOsteomed LP201037—
+2K071877Lanx Spinal Fixation SystemLanx, LLC200775—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospine20230—
+3K231807primaLOK™ SP Interspinous Fusion SystemWenzel Spine, Inc.20230—
+3K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+3K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA…Spinal Simplicity, LLC20223—
+3K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA…Spinal Simplicity, LLC20215—
+3K200066Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC20206—
+3K201704CoFix SystemParadigm Spine GmbH20200—
+3K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+3K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+3K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+3K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC20158—
+3K151863Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20152—
+3K133091Zip Mis Interspinous Fusion SystemAurora Spine201314—
+3K130066Spectrum Spine Spinous Process DeviceSpectrum Spine IP Holdings, LLC20130—
+3K131238Affix Spinous Process Plate SystemNuvasive, Inc.201330—
+3K130438Axle Interspinous Fusion SystemX-Spine Systems, Inc.2013181
+3K131156Lanx Spinal Fixation SystemLanx, Inc.20131—
+3K121940Lanx Spinal Fixation SystemLanx, Inc.20128—
+3K103237Lanx Spinal SystemLanx, Inc.201118—
+3K102886CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20112—
+3K102020Vega Span Spinous Process Plate SystemSpinefrontier, Inc.20108—
+3K090252Modification to: Lanx Spinal Fixation SystemLanx, Inc.200918—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20232—
+4K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+4K221399ZIP™ MIS Interspinous Fusion SystemAurora Spine, Inc.20220—
+4K211880Minuteman G5 MIS Fusion PlateSpinal Simplicity, LLC20224—
+4K213266Inspan ScrewLES Fusion SystemLespine Innovations, LLC20213—
+4K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+4K202309Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero…Zimmer Biomet Spine, Inc.20200—
+4K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity20177—
+4K143388Affix IIS Spinous Process Plate SystemNu Vasive, Incorporated20150—
+4K141317Zip Mis Interspinous Fusion SystemAurora Spine, Inc.20142—
+4K140715Zip Mis Interspinous Fusion SystemAurora Spine, Inc.20143—
+4K133052Affix (R) Next Gen Spinous Process Plate SystemNuvasive, Inc.201318—
+4K120399Lanx Spinal Fixation SystemLanx, LLC201217—
+5K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20241—
+5K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+5K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+6K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLC20250—
+6K171838TiLock2 Spinal SystemGenesys Spine20174—
+6K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+7K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+7K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+7K172469TiLock Modular Spinal SystemGenesys Spine20170—
+8K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+9K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—