BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Bone Cement

    PMA: P810020 · Supplement: S004 · Decision Jul 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81

    Basic Information

    Device Name
    Bone Cement
    Trade Name
    PALACOS E-FLOW (OSTEOPAL) BONE CEMENT
    PMA Number
    P810020
    Supplement Number
    S004
    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 30, 1998
    Date Received
    July 20, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes in the bone cement composition. The device, as modified, will be marketed under the trade name Osteopal (E-Flow) and is indicated for use as a bone cement in arthroplastic procedures of the hip, knee, and other joins to fix plastic and metal prosthetic parts to living bone when recondstruction is necessary because of osteoarthritis, nonunion of fractures of the neck of the femur, sickle cell anemai, osteoporosis, secondary severe joint destruction following trauma or toehr conditions (also for fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures.

    Classifications

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

    Product Code Device Name
    LOD Bone Cement