BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ORTHOFIX AXIALEXTERNAL FIXATION SYS.

    K Number: K802814 · Decision Dec 10, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    84
    Applicant Total
    7
    Review Days
    33

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    Basic Information

    Device Name
    ORTHOFIX AXIALEXTERNAL FIXATION SYS.
    K Number
    K802814
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Cintor Orthopaedic Div.
    Date Received
    November 7, 1980
    Decision Date
    December 10, 1980
    Product Code
    JEC
    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
    JEC Component, Traction, Invasive

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