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

    LEFORTE NEURO SYSTEM BONE PLATE

    K Number: K112812 · Decision Feb 22, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    41
    Applicant Total
    53
    Review Days
    148

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    Basic Information

    Device Name
    LEFORTE NEURO SYSTEM BONE PLATE
    K Number
    K112812
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jeil Medical Corporation
    Date Received
    September 27, 2011
    Decision Date
    February 22, 2012
    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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