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

    NEWFIX EXTERNAL FIXATION SYSTEM

    K Number: K122210 · Decision Apr 19, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    249
    Registration Numbers
    249
    Same Product Code
    403
    Applicant Total
    2
    Review Days
    268

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    Basic Information

    Device Name
    NEWFIX EXTERNAL FIXATION SYSTEM
    K Number
    K122210
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tecnologia Y Diseno Industrial, S.A DE C.V
    Date Received
    July 25, 2012
    Decision Date
    April 19, 2013
    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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    Other Clearances by Tecnologia Y Diseno Industrial, S.A DE C.V

    K Number Device Name
    K101254 NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM