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510(k) Data Aggregation

    K Number
    K191749
    Device Name
    TIGR Matrix Surgical Mesh, TIGR Surgical Mesh
    Manufacturer
    Novus Scientific AB
    Date Cleared
    2020-03-26

    (269 days)

    Product Code
    OWT, FTL, OOD
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Novus Scientific AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TIGR Matrix Surgical Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as for the repar of hernias or other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result.
    Device Description
    The TIGR™ Matrix Surgical Mesh is knitted from two different synthetic resorbable fibers. possessing different degradation characteristics. The fast-resorbing fiber, making up approximately 40% of the matrix by weight, is a copolymer of glycolide, lactide, and trimethylene carbonate. The slow-resorbing fiber, making up approximately 60% of the matrix by weight, is a copolymer of lactide, and trimethylene carbonate. Both fibers degrade by bulk hydrolysis once implanted, resulting in a decreasing strength retention followed by mass loss of the fibers. In vitro testing showed that the fast-resorbing fiber (glycolide, lactide and trimethylene carbonate) loses its mechanical strength after 2 weeks and in vivo studies in the abdominal wall of sheep showed that the fast-resorbing fiber is fully absorbed after 4 months. The same in vitro testing showed that the slow-resorbing fiber (lactide and trimethylene carbonate) maintains its mechanical strength for 6 months and in vivo studies in the abdominal wall of sheep indicated that the slow-resorbing fiber is absorbed after approximately 36 months.
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    K Number
    K163005
    Device Name
    TIGR Matrix Surgical Mesh
    Manufacturer
    NOVUS SCIENTIFIC AB
    Date Cleared
    2017-07-27

    (272 days)

    Product Code
    OWT
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVUS SCIENTIFIC AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TIGR® Matrix Surgical Mesh is intended for use in reinforcement of soft tissue where weakness exists.
    Device Description
    TIGR® Matrix Surgical Mesh is knitted from two different synthetic resorbable fibers, possessing different degradation characteristics. The fast-resorbing fiber, making up approximately 40% of the matrix by weight, is a copolymer of glycolide, lactide, and trimethylene carbonate. The slow-resorbing fiber, making up approximately 60% of the matrix by weight, is a copolymer of lactide, and trimethylene carbonate. Both fibers degrade by bulk hydrolysis once implanted, resulting in a decreasing strength retention followed by mass loss of the fibers.
    Ask a Question

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