BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Bone Cement

    PMA: N17755 · Supplement: S047 · Decision Jul 31, 1996
    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
    S047
    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
    July 31, 1996
    Date Received
    June 21, 1996
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF TERMINOLOGY OF "HALF BATCH, SINGLE BATCH, DOUBLE BATCH, HALF PACK, SINGLE PACK, AND DOUBLE PACK" TO THE PACKAGE LABELS FOR OSTEOBOND COPOLYMER BONE CEMENT

    Classifications

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

    Product Code Device Name
    LOD Bone Cement