BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Filler, Bone Void, Non-Osteoinduction

    PMA: P900039 · Supplement: S010 · Decision Dec 7, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Filler, Bone Void, Non-Osteoinduction
    Trade Name
    COLLAGRAFT STRIP BONE GRAFT MATRIX
    PMA Number
    P900039
    Supplement Number
    S010
    Device Class
    FDA Class 3
    Product Code
    MBS
    Generic Name
    Filler, bone void, non-osteoinduction
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 7, 1998
    Date Received
    November 23, 1998
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes to your manufacturing process. These changes involve 1) moving some of the manufacturing operations currently performed in a Class 100 room to a "controlled" environment that provides the equivalent of a Class 10,000 environment, 2) increasing the "hold" time between the remisturization and irradiation processes, and 3) eliminating both the protein concentration assay for past homogenate mixing and the LAL pyrogenicity assay, as described in the supplement.

    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