BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Finger, Constrained, Metal/Polymer

    PMA: P960053 · Decision Jun 19, 1997
    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
    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 19, 1997
    Date Received
    December 24, 1996
    Expedited Review
    N
    Docket Number
    97M-0393

    Advisory Committee Statement

    APPROVAL FOR THE AVANTA BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS. THIS DEVICE IS INDICATED FOR TOTAL JOINT REPLACEMENT IN SKELETALLY MATURE PATIENTS WITH PAIN OR INSTABILITY OF THE TRAPEZO-METACARPAL JOINT DUE TO TRAUMA, INFLAMMATORY OR DEGENERATIVE DISEASE OR REVISION OF PREVIOUS PROCEDURES, AS AN ALTERNATIVE TO ARTHRODESIS OR RECONSTRUCTIVE SURGERY.

    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