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510(k) Data Aggregation

    K Number
    K142484
    Device Name
    Sternal Closure System
    Manufacturer
    Date Cleared
    2014-10-31

    (57 days)

    Product Code
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    JACE Medical LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sternal Closure System is intended for use in the stabilization of fractures of the sternum, including sternal fixation following sternotomy and sternal reconstructive surgical procedures.
    Device Description
    The Sternal Closure System is comprised of bone screw, bone plate and fastener components and instruments for implantation. The plates are offered in a fixed one-piece and a fastenable two-piece style. Bone screws are available in a single diameter having a range of lengths. The interconnecting components come in solid and cable versions and fasten the halves of the two-piece plate.
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