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

    TRACER DYNAMIC AXIAL FIXATION

    K Number: K892638 · Decision Aug 11, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    84
    Applicant Total
    1
    Review Days
    121

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    Basic Information

    Device Name
    TRACER DYNAMIC AXIAL FIXATION
    K Number
    K892638
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Tracer Medical
    Date Received
    April 12, 1989
    Decision Date
    August 11, 1989
    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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