BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Bone Cement

    PMA: N17004 · Supplement: S011 · Decision Mar 18, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81

    Basic Information

    Device Name
    Bone Cement
    Trade Name
    SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT
    PMA Number
    N17004
    Supplement Number
    S011
    Device Class
    FDA Class 2
    Product Code
    LOD
    Generic Name
    BONE CEMENT
    Regulation Number
    888.3027
    Medical Specialty
    Orthopedic
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 18, 1998
    Date Received
    February 3, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for Isotron Ireland, LTD., to be certified as an alternate supplier for your ETO sterilization process.

    Classifications

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

    Product Code Device Name
    LOD Bone Cement