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510(k) Data Aggregation

    K Number
    K240817
    Device Name
    VersaWrap
    Manufacturer
    Alafair Biosciences Inc.
    Date Cleared
    2024-06-14

    (81 days)

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

    Alafair Biosciences Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VersaWrap is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The device may also be used in the management and protection of surrounding tissues such as skeletal muscle and ligaments. In these procedures, VersaWrap may encounter a variety of implanted structures such as anchors, grafts, staples, and sutures.
    Device Description
    VersaWrap® is an absorbable implant (device), designed to serve as an interface between the target tissues to provide a non-constricting, protective encasement. VersaWrap consists of a clear hydrogel (Sheet) and a wetting Solution. The clear Sheet is a thin membrane of alginate and hyaluronic acid. VersaWrap Sheet is easy to handle, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap may encounter a variety of implanted structures such as anchors, grafts, staples. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet a gelatinous, tissue adherent layer (gel). The Solution, comprised of aqueous citrate, is provided sterile, non-pyrogenic, for single use, in a double peel pouch.
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