BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS

    K Number: K071679 · Decision Dec 17, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    302
    Registration Numbers
    302
    Same Product Code
    528
    Applicant Total
    16
    Review Days
    181

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    Basic Information

    Device Name
    METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS
    K Number
    K071679
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3020
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Disc-O-Tech Medical Technologies, Ltd.
    Date Received
    June 19, 2007
    Decision Date
    December 17, 2007
    Product Code
    HSB
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HSB Rod, Fixation, Intramedullary And Accessories

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