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

    MAYFIELD INFINITY SKULL CLAMP

    K Number: K051440 · Decision Sep 20, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    49
    Applicant Total
    29
    Review Days
    110

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    Basic Information

    Device Name
    MAYFIELD INFINITY SKULL CLAMP
    K Number
    K051440
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4460
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Integra Lifesciences Corp.
    Date Received
    June 2, 2005
    Decision Date
    September 20, 2005
    Product Code
    HBL
    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
    HBL Holder, Head, Neurosurgical (Skull Clamp)

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