BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    Intellijoint® Navigation System

    K Number: K191507 · Decision Oct 1, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    381
    Registration Numbers
    381
    Same Product Code
    430
    Applicant Total
    7
    Review Days
    117

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    Basic Information

    Device Name
    Intellijoint® Navigation System
    K Number
    K191507
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Intellijoint Surgical, Inc.
    Date Received
    June 6, 2019
    Decision Date
    October 1, 2019
    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 Intellijoint Surgical, Inc.

    K Number Device Name
    K211876 Intellijoint VIEW
    K172849 Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray
    K171525 Intellijoint HIP Generation 2B System
    K162364 Intellijoint HIP Generation 2A System
    K151364 Intellijoint HIP(tm) System
    K133759 INTELLIJOINT HIP