BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Finger, Constrained, Metal/Polymer

    PMA: P960053 · Supplement: S003 · Decision Dec 31, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Prosthesis, Finger, Constrained, Metal/Polymer
    Trade Name
    BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS
    PMA Number
    P960053
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    KWG
    Generic Name
    Prosthesis, finger, constrained, metal/polymer
    Regulation Number
    888.3220
    Medical Specialty
    Orthopedic
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 31, 2002
    Date Received
    November 8, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT RMS CO., MINNEAPOLIS, MINNESOTA AND A NEW STERILIZATION FACILITY LOCATED AT MICRONET MEDICAL, INC., ST. PAUL, MINNESOTA.

    Classifications

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

    Product Code Device Name
    KWG Prosthesis, Finger, Constrained, Metal/Polymer