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510(k) Data Aggregation

    K Number
    K080259
    Device Name
    JMEA CANNULATED BONE SCREW SYSTEM
    Manufacturer
    Date Cleared
    2008-08-20

    (202 days)

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

    JMEA CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The JMEA cannulated bone screws are used to provide interference fixation of soft tissue grafts in anterior and posterior cruciate ligament repair through arthroscopy or arthrotomy.
    Device Description
    The titanium alloy screw is cylindrical with a tapered tip and has smooth single or double belix thread design. The JMEA cannulated bone screws are and to provide interference fixation of soft tissue grafts in anterior and posterior cruciate ligament repair through arthroscopy or arthrotomy. The screw comes in various lengths and diamsters, resulting in a screw design adapted to the graft norphology and patication anatomy.
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