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

    Remi Robotic Navigation System

    K Number: K223070 · Decision Oct 28, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    381
    Registration Numbers
    381
    Same Product Code
    430
    Applicant Total
    2
    Review Days
    28

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    Basic Information

    Device Name
    Remi Robotic Navigation System
    K Number
    K223070
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fusion Robotics, LLC
    Date Received
    September 30, 2022
    Decision Date
    October 28, 2022
    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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    Other Clearances by Fusion Robotics, LLC

    K Number Device Name
    K223350 Remi Robotic Navigation System