BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Bone Cement

    PMA: N17755 · Supplement: S046 · Decision Nov 20, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81

    Basic Information

    Device Name
    Bone Cement
    Trade Name
    OSTEOBOND(TM) COPOLYMER BONE CEMENT
    PMA Number
    N17755
    Supplement Number
    S046
    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
    October 11, 1995
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION TO THE LABELING OF THE FOLLOWING WARNING STATEMENT: "DO NOT CENTRIGUGE OSTEOBOND COPOLYMER BONE CEMENT. ALTHOUGH CENTRIFUGATION HAS BEEN SHOWN IN SOME CASES TO IMPROVE THE PHYSICAL STRENGTH OF THE CURED CEMENT BY REMOVAL OF ENTRAPPED AIR AND OTHER GASES, A UNIFORM DISPERSION OF THE RADIOPACIFIER CANNOT BE ASSURED. THEREFORE, THE USE OF CENTRIGUGATION IS NOT ADVISABLE."

    Classifications

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

    Product Code Device Name
    LOD Bone Cement