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

    Sequel External Fixation Device

    K Number: K202833 · Decision Jan 19, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    249
    Registration Numbers
    249
    Same Product Code
    403
    Applicant Total
    1
    Review Days
    116

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    Basic Information

    Device Name
    Sequel External Fixation Device
    K Number
    K202833
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sequel Medical, Inc.
    Date Received
    September 25, 2020
    Decision Date
    January 19, 2021
    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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