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510(k) Data Aggregation

    K Number
    K190996
    Device Name
    Bonus Therapeutics Mixing and Delivery System
    Date Cleared
    2019-07-28

    (103 days)

    Product Code
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bonus Therapeutics Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bonus Therapeutics Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to surgical sites.
    Device Description
    The Bonus Therapeutics Mixing and Delivery System comprises a sterile piston syringe with an end cap, a cannulated applicator tip and a pusher rod. The syringe consists of syringe barrel with a plunger and an integrated mixing rod to enable mixing of the grafting material prior to application. The open bore barrel enables the loading of viscous grafting material by transferring it directly into the sterile syringe. The plunger sleeve is removable, and when removed it exposes the integrated mixing rod; a rotatable rod with four diagonal blades which allow mixing of the material as needed prior to injection, while maintained in the closed syringe barrel. When the plunger sleeve is attached, it operates as a simple piston to allow the extrusion of the material from the syringe. The Cannula may be attached to the syringe via the Luer connection to facilitate the delivery of grafting material to the surgical site. The Pusher may be used to release grafting material remaining in the Cannula. The system is supplied sterile for single use.
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