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

    MECRON CONCAVEX FLEXIBLE INTRAMEDULLARY

    K Number: K820852 · Decision Apr 15, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    302
    Registration Numbers
    302
    Same Product Code
    528
    Applicant Total
    6
    Review Days
    20

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    Basic Information

    Device Name
    MECRON CONCAVEX FLEXIBLE INTRAMEDULLARY
    K Number
    K820852
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3020
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Serrano Intl.
    Date Received
    March 26, 1982
    Decision Date
    April 15, 1982
    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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