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

    CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM

    K Number: K040864 · Decision Jun 17, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    55
    Applicant Total
    10
    Review Days
    76

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    Basic Information

    Device Name
    CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM
    K Number
    K040864
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aesculap
    Date Received
    April 2, 2004
    Decision Date
    June 17, 2004
    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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