BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SX-One MicroKnife

    K Number: K192873 · Decision Dec 20, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    1140
    Registration Numbers
    1140
    Same Product Code
    57
    Applicant Total
    1
    Review Days
    73

    Basic Information

    Device Name
    SX-One MicroKnife
    K Number
    K192873
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sonex Health, Inc.
    Date Received
    October 8, 2019
    Decision Date
    December 20, 2019
    Product Code
    LXH
    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
    LXH Orthopedic Manual Surgical Instrument

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