BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Bone Cement

    PMA: N18466 · Supplement: S020 · Decision Nov 20, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81

    Basic Information

    Device Name
    Bone Cement
    Trade Name
    CMW BONE CEMENT, CMW 1, CMW 1 RADIOPAQUE, CMW 2, AND CMW 3 BONE CEMENTS.
    PMA Number
    N18466
    Supplement Number
    S020
    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
    November 20, 1995
    Date Received
    September 28, 1995
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING:1)ADDITION OF A DISTRIBUTOR LABEL TO BE PLACED ON TO THE BOTTOM OF THE OUTER CARTON; AND 2) THE STERILE POWDER PACKAGE WILL BE PLACED INTO A NONSTERILE PROTECTIVE LAMINATED FOIL POUCH

    Classifications

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

    Product Code Device Name
    LOD Bone Cement