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510(k) Data Aggregation

    K Number
    K152967
    Device Name
    NERBRIDGE
    Manufacturer
    Date Cleared
    2016-06-22

    (258 days)

    Product Code
    Regulation Number
    882.5275
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOYOBO CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Nerbridge™ is intended for the repair of peripheral nerve injuries in which there is no gap or where a gap closure can be achieved by flexion of the extremity.
    Device Description
    Nerbridge™ is a product composed of polyglycolic acid and collagen derived from porcine skin. Nerbridge™ is a flexible, resorbable and semipermeable tubular membrane matrix filled with porous collagen that provides a non-constricting encasement for injured peripheral nerves for protection of the neural environment. Nerbridge™ is designed to be an interface between the nerve and the surrounding tissue. When hydrated, Nerbridge™ is a pliable, soft, non-friable, porous conduit. The resilience of Nerbridge allows the product to recover and maintain closure without constricting the nerve once the device is placed around the nerve. Nerbridge™ is manufactured using validated viral inactivation and removal processes for the collagen. The product is provided in a foil pouch, sterile, nonpyrogenic, for single use only, in a variety of sizes, and placed in an outer Tyvek header bag for added protection.
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