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

    XTRAFIX EXTERNAL FIXATION SYSTEM

    K Number: K111155 · Decision Oct 20, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    247
    Registration Numbers
    247
    Same Product Code
    392
    Applicant Total
    1
    Review Days
    178

    Basic Information

    Device Name
    XTRAFIX EXTERNAL FIXATION SYSTEM
    K Number
    K111155
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    EXTRAORTHO INC
    Date Received
    April 25, 2011
    Decision Date
    October 20, 2011
    Product Code
    KTT
    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
    KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

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