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510(k) Data Aggregation

    K Number
    K210997
    Device Name
    PreferX Delivery System
    Manufacturer
    Date Cleared
    2021-09-07

    (158 days)

    Product Code
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    MD3 LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PREFERX Delivery System is intended to be used for the delivery of hydrated allograft, or synthetic bone graft material to an orthopedic surgical site.
    Device Description
    The PREFERX Delivery System is a single use pre-sterilized and disposable system consisting of a Feeder including a CC Body, Stand, and Funnel; a Reduction Sleeve; a BC-Sleeve and BC-Sleeve Cap, used to load the graft material into the Biologic Cartridge. The Biologic Cartridge contains and delivers the graft material to the surgical site. A Plunger expresses the graft material from the Biologic Cartridge through an actuating trigger on the Gun that advances the Plunger down the length of the Biologic Cartridge via a ratcheting mechanism. The system is designed such that the Biologic Cartridge can be filled with the desired graft material, attached to the Gun and Plunger for use, then removed and refilled during the same procedure. The Biologic Cartridge does not have a Luer lock mechanism; the device does not require a needle or similar attachment; the Biologic Cartridge contents being dispensed directly from the tip of the Biologic Cartridge into the graft site. The device is packaged in a thermoformed tray with a Tyvek lid. Each tray is then packaged individually in an outer paperboard carton. The PREFERX Delivery System is a single use pre-sterilized, disposable system intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
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