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

    OsteoFab Patient Specific Cranial Device

    K Number: K180064 · Decision Jul 27, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    55
    Applicant Total
    3
    Review Days
    199

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    Basic Information

    Device Name
    OsteoFab Patient Specific Cranial Device
    K Number
    K180064
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5330
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Oxford Performance Materials, Inc.
    Date Received
    January 9, 2018
    Decision Date
    July 27, 2018
    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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    Other Clearances by Oxford Performance Materials, Inc.

    K Number Device Name
    K190915 OsteoFab Suture Anchors
    K161052 OsteoFab Patient Specific Facial Device