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

    CHARNLEY DESIGN HIP PROSTHESIS

    K Number: K801006 · Decision May 20, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    58
    Applicant Total
    7
    Review Days
    22

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    Basic Information

    Device Name
    CHARNLEY DESIGN HIP PROSTHESIS
    K Number
    K801006
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3360
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Colmed, Ltd.
    Date Received
    April 28, 1980
    Decision Date
    May 20, 1980
    Product Code
    JDG
    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
    JDG Prosthesis, Hip, Femoral Component, Cemented, Metal

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