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

    ARVIS Surgical Navigation System

    K Number: K203115 · Decision Jul 14, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    381
    Registration Numbers
    381
    Same Product Code
    430
    Applicant Total
    2
    Review Days
    271

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    Basic Information

    Device Name
    ARVIS Surgical Navigation System
    K Number
    K203115
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Insight Medical Systems, Inc.
    Date Received
    October 16, 2020
    Decision Date
    July 14, 2021
    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 Insight Medical Systems, Inc.

    K Number Device Name
    K240062 ARVIS® Shoulder