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

    STRYKER LEIBINGER CRANIAL FIXATION SYSTEM

    K Number: K030378 · Decision Mar 20, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    55
    Applicant Total
    74
    Review Days
    43

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    Basic Information

    Device Name
    STRYKER LEIBINGER CRANIAL FIXATION SYSTEM
    K Number
    K030378
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Instruments
    Date Received
    February 5, 2003
    Decision Date
    March 20, 2003
    Product Code
    GXN
    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
    GXN Plate, Cranioplasty, Preformed, Non-Alterable

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