BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Universal Mesh - Sterile

    K Number: K182425 · Decision Nov 6, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    41
    Applicant Total
    21
    Review Days
    61

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    Basic Information

    Device Name
    Universal Mesh - Sterile
    K Number
    K182425
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Leibinger GmbH & Co KG
    Date Received
    September 6, 2018
    Decision Date
    November 6, 2018
    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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