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510(k) Data Aggregation

    K Number
    K192452
    Device Name
    Lyograft
    Manufacturer
    B. Bruan Surgical, SA
    Date Cleared
    2020-09-03

    (360 days)

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

    B. Bruan Surgical, SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lyograft® is intended for implantation to repair, reinforce and/or supplement soft tissue.
    Device Description
    Lyograft is a biological surgical mesh comprised of pure collagen made of bovine pericardium. It is a single layered membrane of connective tissue with the collagen fibers running in three dimensions. Lyophilization causes the formation of a mesh, free of non-collagenous components, with a loose fibrous structure and large communicating pores. Lyograft is a long-term implant that will be incorporated into the patient's tissue over time. Lyograft is supplied in various sizes ranging from 8x14cm to 20x30cm. It is provided sterile within a double blister package and is for single use. Lyograft is rehydrated in a physiological saline solution and cut to size using aseptic technique prior to use. It is recommended to suture Lyograft in place using nonabsorbable sutures.
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