BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    INTAI Surgery Navigation System

    K Number: K180523 · Decision Sep 20, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    381
    Registration Numbers
    381
    Same Product Code
    430
    Applicant Total
    2
    Review Days
    570

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    Basic Information

    Device Name
    INTAI Surgery Navigation System
    K Number
    K180523
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Intai Technology Corporation
    Date Received
    February 27, 2018
    Decision Date
    September 20, 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 Intai Technology Corporation

    K Number Device Name
    K201229 Intai Anatomic Locking Plate and Screw System