BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM

    K Number: K042458 · Decision Oct 7, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    56
    Applicant Total
    6
    Review Days
    27

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    Basic Information

    Device Name
    A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM
    K Number
    K042458
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    A.M. Surgical, Inc.
    Date Received
    September 10, 2004
    Decision Date
    October 7, 2004
    Product Code
    LXT
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

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