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510(k) Data Aggregation

    K Number
    K200226
    Device Name
    RetroFix
    Date Cleared
    2020-06-26

    (148 days)

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

    Retrofix Screws, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RetroFix screw is a cannulated tapered screw intended to be used as stand-alone bone screw for internal bone fixation for bone fractures of the ankle.
    Device Description
    The RetroFix screw is a cannulated tapered screw intended to be used as a stand-alone bone screw for internal bone fixation for bone fractures of the ankle. The screw shaft has a predetermined length with a cannula extending through the length of the shaft. The shaft has a relatively large outside diameter proximal segment, a smaller outside diameter threaded distal segment, and a flared end. The proximal segment and the distal segment are unitary. The cannula is adapted for use with a surgical K-wire. The screws have cortical threads and come in many different sizes, varying in diameter and lengths. The device does not come sterile and must be sterilized prior to use.
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