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510(k) Data Aggregation

    K Number
    K090686
    Device Name
    SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS
    Manufacturer
    SIC BREVETTI S.R.L.
    Date Cleared
    2009-12-08

    (267 days)

    Product Code
    JDQ
    Regulation Number
    888.3010
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIC BREVETTI S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Device for Sternal Synthesis is indicated for closure and repair of the sternum after sternotomy to stabilize the sternum and promote fusion.
    Device Description
    The Device for Sternal Synthesis is a surgical implant that is available in two sizes manufactured of unalloyed titanium sheet. It is applied to the anterior surface of the sternum and inferior surfaces of the adjacent ribs on both the left and right sides of the sternum. It is circumferentially secured with monofilament surgical steel sutures.
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