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

    AOS ES Retrograde Femoral Nail

    K Number: K191598 · Decision Jul 18, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    302
    Registration Numbers
    302
    Same Product Code
    528
    Applicant Total
    23
    Review Days
    31

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    Basic Information

    Device Name
    AOS ES Retrograde Femoral Nail
    K Number
    K191598
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3020
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Orthopaedic Solutions, Inc.
    Date Received
    June 17, 2019
    Decision Date
    July 18, 2019
    Product Code
    HSB
    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
    HSB Rod, Fixation, Intramedullary And Accessories

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