BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    Optimus NEURO System - Sterile Kit

    K Number: K190811 · Decision Nov 27, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    41
    Applicant Total
    20
    Review Days
    243

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    Basic Information

    Device Name
    Optimus NEURO System - Sterile Kit
    K Number
    K190811
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osteonic Co., Ltd.
    Date Received
    March 29, 2019
    Decision Date
    November 27, 2019
    Product Code
    GWO
    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
    GWO Plate, Cranioplasty, Preformed, Alterable

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    K231322 Fix2Lock(PEEK Self Punching)
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