BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Bone Cement

    PMA: P960001 · Decision Feb 11, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81

    Basic Information

    Device Name
    Bone Cement
    Trade Name
    DEPUY 1 BONE CEMENT
    PMA Number
    P960001
    Device Class
    FDA Class 2
    Product Code
    LOD
    Generic Name
    BONE CEMENT
    Regulation Number
    888.3027
    Medical Specialty
    Orthopedic
    Advisory Committee
    Orthopedic
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    February 11, 1997
    Date Received
    January 11, 1996
    Expedited Review
    N
    Docket Number
    97M-0255

    Advisory Committee Statement

    APPROVAL FOR THE DEPUY 1 BONE CEMENT. THIS DEVICE IS INDICATED FOR THE FIXATION OF PROSTHESES TO LIVING BONE IN ORTHOPEDIC MUSCULOSKELETAL SURGICAL PROCEDURES FOR THEUMATOID ARTHRITIS, OSTEOARTHRITIS, TRAUMATIC ARTHRITIS, OSTEOPOROSIS, AVASCULAR NECROSIS, COLLAGEN DISEASE, SEVERE JOINT DESTRUCTION SECONDARY TO TRAUMA OR OTHER CONDITIONS AND REVISION OF PREVIOUS ARTHOROPLASTY.

    Classifications

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

    Product Code Device Name
    LOD Bone Cement