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

    OsteoVation Impact

    K Number: K162864 · Decision Jan 13, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    43
    Applicant Total
    10
    Review Days
    92

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    Basic Information

    Device Name
    OsteoVation Impact
    K Number
    K162864
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5300
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Skeletal Kinetics, LLC
    Date Received
    October 13, 2016
    Decision Date
    January 13, 2017
    Product Code
    GXP
    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
    GXP Methyl Methacrylate For Cranioplasty

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