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510(k) Data Aggregation

    K Number
    K142873
    Device Name
    OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners
    Manufacturer
    C.R.Bard Inc.
    Date Cleared
    2015-03-12

    (162 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™ Absorbable Fixation System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.
    Device Description
    The OptiFix™ Absorbable Fixation System is a sterile (via gamma) single use product that is comprised of a deployment component and an absorbable fastener component. Two product ordering codes are to be packaged for distribution; each contains the same ergonomically designed deployment device. The variation will be the preloaded fasteners; either 15 or 30. The shaft of the OptiFix™ Absorbable Fixation System is 39 cm in length and is designed for use with 5mm trocars. The fasteners are designed with retention features and are manufactured from Poly (D, L)-lactide.
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