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510(k) Data Aggregation

    K Number
    K201676
    Device Name
    Barricaid Instrument Tray
    Date Cleared
    2020-07-16

    (27 days)

    Product Code
    Regulation Number
    888.4510
    Why did this record match?
    Product Code :

    QHG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Intrinsic Therapeutics Defect Measurement Tool for the Barricaid® Annular Closure Device is intended to aid in determining if a patient meets the indications for the Barricaid® Annular Closure Device by assessing the defect size in the annulus fibrosus following limited discectory. This tool is indicated to only be used with the Intrinsic Therapeutics Barricaid® Annular Closure Device.
    Device Description
    The Barricaid® Instrument kit contains a number of manual surgical instruments as well as the Defect Measurement Tool. This kit is provided with all of the instruments with a sterilization tray. The Defect Measurement Tool is intended to measure the annular defect to determine if a patient meets the indications for use for the Barricaid® Annular Closure Device. All instruments are made from stainless steel. This kit is intended to be used only with the Intrinsic Therapeutics Barricaid® Annular Closure Device (ACD). The purpose of this submission is to modify and reduce the size of the sterilization tray used to contain the reusable instruments necessary to surgically implant or remove the Barricaid® Annular closure device.
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