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

    Intellijoint VIEW

    K Number: K211876 · Decision Nov 12, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    4
    Review Days
    148

    Basic Information

    Device Name
    Intellijoint VIEW
    K Number
    K211876
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Intellijoint Surgical Inc.
    Date Received
    June 17, 2021
    Decision Date
    November 12, 2021
    Product Code
    LLZ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LLZ System, Image Processing, Radiological

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    Other Clearances by Intellijoint Surgical Inc.

    K Number Device Name
    K191507 Intellijoint® Navigation System
    K172849 Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray
    K171525 Intellijoint HIP Generation 2B System