BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Drill Guide; Drill Bit; Spine & Trauma Navigation

    K Number: K240701 · Decision May 23, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    381
    Registration Numbers
    381
    Same Product Code
    430
    Applicant Total
    135
    Review Days
    70

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    Basic Information

    Device Name
    Drill Guide; Drill Bit; Spine & Trauma Navigation
    K Number
    K240701
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Brainlab AG
    Date Received
    March 14, 2024
    Decision Date
    May 23, 2024
    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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