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

    X-Guide Surgical Navigation System

    K Number: K192579 · Decision Feb 3, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    22
    Applicant Total
    5
    Review Days
    137

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    Basic Information

    Device Name
    X-Guide Surgical Navigation System
    K Number
    K192579
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4120
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    X-Nav Technologies, LLC
    Date Received
    September 19, 2019
    Decision Date
    February 3, 2020
    Product Code
    PLV
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PLV Dental Stereotaxic Instrument

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    Other Clearances by X-Nav Technologies, LLC

    K Number Device Name
    K232148 X-Guide Surgical Navigation System
    K211701 X-Guide® Surgical Navigation System
    K200662 X-Guide® Surgical Navigation System
    K150222 X-Guide Surgical Navigation System