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510(k) Data Aggregation

    K Number
    K223445
    Device Name
    ArtiFascia
    Manufacturer
    Nurami Medical Ltd.
    Date Cleared
    2023-08-10

    (269 days)

    Product Code
    GXQ
    Regulation Number
    882.5910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nurami Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ArtiFascia is indicated as dura substitute for the repair of dura mater. ArtiFascia is indicated for defects of 25cm² (3.87 in²) or less in area. For example, 6 cm X 4 cm (24 cm²) would be an acceptable defect size.
    Device Description
    ArtiFascia is an absorbable dural repair graft for the repair of cranial dural defects. ArtiFascia is a highly flexible, easy to handle, non-friable soft matrix composed of synthetic non-woven fibers and a non-porous film. ArtiFascia is packaged in a single-use peelable package and is provided sterile, nonpyrogenic. ArtiFascia readily conforms to the surface of the wound area and is applied to the dural defect by using sutures.
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