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

    MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)

    K Number: K140462 · Decision Jun 13, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    41
    Applicant Total
    45
    Review Days
    109

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    Basic Information

    Device Name
    MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)
    K Number
    K140462
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes (USA) Products, LLC
    Date Received
    February 24, 2014
    Decision Date
    June 13, 2014
    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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