BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Bone Cement

    PMA: N18466 · Supplement: S023 · Decision Oct 21, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81

    Basic Information

    Device Name
    Bone Cement
    Trade Name
    ORTHOSET BONE CEMENT
    PMA Number
    N18466
    Supplement Number
    S023
    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
    October 21, 1998
    Date Received
    October 1, 1998
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval to remove the ascorbic acid and ethanol components from the liquid monomer formulation in your Orthoset 1, Orthoset 2, and Orthoset 3 bone cements, as well as approval to omit the quality control test for dimensional change from the finished product specification.

    Classifications

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

    Product Code Device Name
    LOD Bone Cement