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510(k) Data Aggregation

    K Number
    K013059
    Device Name
    STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)
    Manufacturer
    STONY BROOK SURGICAL INNOVATIONS, INC.
    Date Cleared
    2001-10-22

    (41 days)

    Product Code
    GAQ
    Regulation Number
    878.4495
    Why did this record match?
    Applicant Name (Manufacturer) :

    STONY BROOK SURGICAL INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stony Brook Surgical Innovations' (SBSI) Sterna-Wire is a non-absorbable Stainless Steel Wire with an attached needle that is used during thoracic surgery to close and hold the sternum after a median sternotomy. The Sterna-Wire remains in the Sternum indefinitely and is not removed.
    Device Description
    Sterna-Wire is indicated for use in the Sternal Closure. Sterna-Wire is a non absorbable sterile surgical suture composed of 316L stainless steel. The wire material consists of 18" (45cm) 316L stainless steel surgical suture wire and the needle material is a 420 stainless steel sharp semi-circular needle, sterile, nonabsorbable, single use. The product will be packaged as 2 wires, 2 sterna-band and 4 wires, 4 sterna-band and 2 wires, and 2 sterna-band products.
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