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

    StealthStation S8 Spine Software v1.0.0

    K Number: K170011 · Decision May 1, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    381
    Registration Numbers
    381
    Same Product Code
    430
    Applicant Total
    9
    Review Days
    118

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    Basic Information

    Device Name
    StealthStation S8 Spine Software v1.0.0
    K Number
    K170011
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Navigation
    Date Received
    January 3, 2017
    Decision Date
    May 1, 2017
    Product Code
    OLO
    Advisory Committee
    Neurology
    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
    OLO Orthopedic Stereotaxic Instrument

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