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

    LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X

    K Number: K082679 · Decision Apr 7, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    84
    Applicant Total
    10
    Review Days
    204

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    Basic Information

    Device Name
    LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X
    K Number
    K082679
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sintea Biotech, Inc.
    Date Received
    September 15, 2008
    Decision Date
    April 7, 2009
    Product Code
    JEC
    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
    JEC Component, Traction, Invasive

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