BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Finger, Constrained, Metal/Polymer

    PMA: P960053 · Supplement: S001 · Decision Jun 4, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Prosthesis, Finger, Constrained, Metal/Polymer
    Trade Name
    TOTAL TRAPEZIO METACARPAL PROSTHESIS
    PMA Number
    P960053
    Supplement Number
    S001
    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
    June 4, 1998
    Date Received
    March 31, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR 1) PACKAGING THE IMPLANT IN A SINGLE BOX CONTAINING BOTH THE PROXIMAL AND DISTAL COMPONENTS AND CHANGING PACKAGE LABELS ACCORDINGLY, AND 2) CHANGING THE COLOR OF STOCK USED FOR PRINTING BOX LABELS.

    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