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

    SYNTHES SCOUT TACK FIXATION

    K Number: K111048 · Decision Jun 14, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    9
    Applicant Total
    36
    Review Days
    426

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    Basic Information

    Device Name
    SYNTHES SCOUT TACK FIXATION
    K Number
    K111048
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3470
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Synthes Spine
    Date Received
    April 15, 2011
    Decision Date
    June 14, 2012
    Product Code
    OMR
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OMR Vessel Guard Or Cover

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