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510(k) Data Aggregation

    K Number
    K153211
    Device Name
    M-Fix Acromioclavicular Device
    Date Cleared
    2016-02-02

    (89 days)

    Product Code
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    CORACOID SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The M-Fix™ Acromioclavicular Device is intended to provide fixation during the healing process following syndesmotic trauma such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
    Device Description
    The M-Fix™ Acromioclavicular Device (M-Fix™) is a suture band system designed to provide reduction and stabilization of the acromioclavicular joint following syndesmotic disruptions. The M-Fix is a polyethylene terephthalate (PET) band that may be tensioned and secured with the integrated, low-profile Connector/Button which is made of titanium or stainless steel. The one-time use band with connector is provided sterile. Additional accessory instruments, including a Counter Traction Tool and a Punch Tool for securing the Connector/Button are single use devices provided sterile for use during the orthopedic procedure.
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