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510(k) Data Aggregation

    K Number
    K163698
    Device Name
    OptiFix Open Absorbable Fixation System - 20 absorbable fasteners
    Manufacturer
    C.R. BARD INC,
    Date Cleared
    2017-04-11

    (103 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    C.R. BARD INC,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OptiFix™ Open Absorbable Fixation System is indicated for the fixation of surgical mesh to tissues during open surgical procedures, such as hernia repair.
    Device Description
    The OptiFix" Open Absorbable Fixation System, hereinafter referred to as "OptiFix" Open", is a sterile (via gamma) single use device that is comprised of a deployment component and an absorbable fastener component. The device delivers 20 synthetic absorbable fasteners via a curved shaft. The shaft of the OptiFix™ Open Absorbable Fixation System is 27cm in length. The fasteners are 6.7mm in length, are manufactured from Poly (D, L)-lactide and are dyed with D & C Violet No. 2.
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