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

    INLIANT Surgical Navigation System

    K Number: K213392 · Decision Feb 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    130

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    Basic Information

    Device Name
    INLIANT Surgical Navigation System
    K Number
    K213392
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4120
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Navigate Surgical Technologies, Inc.
    Date Received
    October 15, 2021
    Decision Date
    February 22, 2022
    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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