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

    MONDEAL DISTAL RADIUS SYSTEM

    K Number: K071798 · Decision Sep 17, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    505
    Registration Numbers
    505
    Same Product Code
    1254
    Applicant Total
    6
    Review Days
    77

    Basic Information

    Device Name
    MONDEAL DISTAL RADIUS SYSTEM
    K Number
    K071798
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MONDEAL MEDICAL SYSTEMS GMBH
    Date Received
    July 2, 2007
    Decision Date
    September 17, 2007
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

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