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

    KIRSCHNER ORTHOPEDIC WIRE, EYELET CERCLAGE WIRES

    K Number: K850631 · Decision May 1, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    128
    Applicant Total
    76
    Review Days
    71

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    Basic Information

    Device Name
    KIRSCHNER ORTHOPEDIC WIRE, EYELET CERCLAGE WIRES
    K Number
    K850631
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3010
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Kirschner Medical Corp.
    Date Received
    February 19, 1985
    Decision Date
    May 1, 1985
    Product Code
    JDQ
    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
    JDQ Cerclage, Fixation

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