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510(k) Data Aggregation

    K Number
    K223860
    Device Name
    Integrity™ Bone Staple Fixation System
    Manufacturer
    Anika Therapeutics Inc.
    Date Cleared
    2023-05-22

    (150 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Anika Therapeutics Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Integrity™ Bone Staple Fixation System is indicated for the fixation of soft tissue grafts or reinforcement meshes to bone during rotator cuff repairs.
    Device Description
    The Integrity™ Bone Staple Fixation System consists of bone staples and a delivery instrument. The bone staple is a staple-shaped tack with barbed ends and is comprised of non-absorbable poly(ether ether ketone) [PEEK]. The bone staples are designed to provide fixation of soft tissue grafts or reinforcement meshes to bone at surgery and are used in conjunction with a Delivery instrument from Anika. The device is sterilized by radiation with a SAL of 10-9. The bone staples and delivery instruments are provided sterile for single use only. The staples are packaged in a caddy within a dual sterile packaging configuration.
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