BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Glenoid Fossa Prosthesis

    PMA: P000035 · Supplement: S009 · Decision Jun 2, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Glenoid Fossa Prosthesis
    Trade Name
    TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM
    PMA Number
    P000035
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    MPI
    Generic Name
    Glenoid fossa prosthesis
    Regulation Number
    872.3950
    Medical Specialty
    Dental
    Advisory Committee
    Dental
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 2, 2014
    Date Received
    March 4, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE BONE SCREW LENGTH TO MATCH THELABELED LENGTHS, TO STANDARDIZE THE SCREW THREAD PROFILE AND PITCH, TO INCREASE THE LENGTH OF THE THREADED PORTION OF THE BONE SCREW, TO ROUND THE TIP OF THE SCREW, TO ADD A FILLET BETWEEN THE SCREW HEAD AND SCREW SHAFT, TO STANDARDIZE DIMENSIONS OF CERTAIN GEOMETRICAL FEATURES OF THE BONE SCREWS (THE SCREW HEAD CROWN RADIUS AND DRIVER SLOT DEPTH), TO STANDARDIZE THE MINOR DIAMETER, AND TO INTRODUCE TI-6AL-4V ALLOY BONE SCREWS.

    Classifications

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

    Product Code Device Name
    MPI Glenoid Fossa Prosthesis