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    K Number
    K141106
    Device Name
    FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM
    Manufacturer
    FOLSOM METAL PRODUCTS, INC. DBA FRONTIER DEVICES
    Date Cleared
    2014-10-10

    (164 days)

    Product Code
    OUR
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    FOLSOM METAL PRODUCTS, INC. DBA FRONTIER DEVICES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FUSIO Screw Fuze System is intended for large bone fixation, including sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
    Device Description
    The Frontier Devices FUSIO Screw Fuze System consists of titanium bone screws of 7mm, 9.5mm, and 11mm diameter of various lengths to accommodate patient anatomy. An optional serrated washer can be placed on the screw. The screws are made from titanium alloy, Ti-6Al-4V, that conforms to the ASTM F136 standard.
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