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

    RADIAL HEAD PROSTHESIS

    K Number: K811451 · Decision Jun 9, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    26
    Applicant Total
    7
    Review Days
    18

    Basic Information

    Device Name
    RADIAL HEAD PROSTHESIS
    K Number
    K811451
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3160
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    CINTOR ORTHOPAEDIC DIV.
    Date Received
    May 22, 1981
    Decision Date
    June 9, 1981
    Product Code
    JDB
    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
    JDB Prosthesis, Elbow, Semi-Constrained, Cemented

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