BEUDAMED
    FDA PMA FDA Class 3 Approved (Reclassification) 🇺🇸 United States

    Filler, Bone Void, Non-Osteoinduction

    PMA: P970010 · Decision Dec 23, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Filler, Bone Void, Non-Osteoinduction
    Trade Name
    NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT
    PMA Number
    P970010
    Device Class
    FDA Class 3
    Product Code
    MBS
    Generic Name
    Filler, bone void, non-osteoinduction
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    December 23, 1998
    Date Received
    February 24, 1997
    Expedited Review
    N
    Docket Number
    99M-4361

    Advisory Committee Statement

    Indicated for use as an adjunct for fracture stabilization in the treatment of low impact, unstable, metaphyseal distal radius fractures, in cases where early mobilization (cast for 2 weeks, then removable splint for 2-4 weeks) is indicated. Use of SRS alone in highly comminuted fractures is not indicated.

    Classifications

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

    Product Code Device Name
    MBS Filler, Bone Void, Non-Osteoinduction