BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Finger, Constrained, Metal/Polymer

    PMA: P960053 · Supplement: S004 · Decision Sep 28, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Prosthesis, Finger, Constrained, Metal/Polymer
    Trade Name
    SBI BRAUN-CUTTER TRAPEZ-METACARPAL PROSTHESIS
    PMA Number
    P960053
    Supplement Number
    S004
    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
    September 28, 2007
    Date Received
    August 24, 2007
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING SITE LOCATED AT PROFESSIONAL CONTRACT STERILIZATION, TAUNTON, MASSACHUSETTS.

    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