BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

    PMA: P070026 · Supplement: S043 · Decision Nov 28, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
    Trade Name
    CERAMAX CERAMIC HIP SYSTEM
    PMA Number
    P070026
    Supplement Number
    S043
    Device Class
    FDA Class 3
    Product Code
    MRA
    Generic Name
    Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 28, 2016
    Date Received
    October 31, 2016
    Supplement Type
    Special
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of a verification step for the manufacturing operator to visually and audibly confirm once per shift that the ultrasonic generators turn on and transducers are audibly energized.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MRA Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented