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

    Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems

    K Number: K161318 · Decision Mar 20, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    42
    Applicant Total
    2
    Review Days
    313

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    Basic Information

    Device Name
    Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems
    K Number
    K161318
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4800
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tedan Surgical Innovations, LLC
    Date Received
    May 11, 2016
    Decision Date
    March 20, 2017
    Product Code
    GZT
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GZT Retractor, Self-Retaining, For Neurosurgery

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