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

    STATIC CRANIOPLASTY ORTHOSIS

    K Number: K063098 · Decision Apr 11, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    22
    Applicant Total
    3
    Review Days
    183

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    Basic Information

    Device Name
    STATIC CRANIOPLASTY ORTHOSIS
    K Number
    K063098
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5970
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Brace Intl., Inc.
    Date Received
    October 10, 2006
    Decision Date
    April 11, 2007
    Product Code
    OAN
    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
    OAN Orthosis, Cranial, Laser Scan

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    Other Clearances by Boston Brace Intl., Inc.

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