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    K Number
    K243580
    Device Name
    GraftGun Universal Graft Delivery System (GDS)
    Manufacturer
    SurGenTec, LLC.
    Date Cleared
    2025-02-05

    (78 days)

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

    SurGenTec, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GraftGun Universal Graft Delivery System (GDS®) is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site, via direct visualization or minimally invasive.
    Device Description
    The GraftGun Universal Graft Delivery System (GDS®) consists of a sterile, single-use, disposable device, and non-sterile reusable Adapter Tips intended for the delivery of prepared allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. The GraftGun Universal Graft Delivery System (GDS®) includes the GraftGun Dispensing Unit, Loading Device, Graft Tubes, and Adapter Tips.
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