LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K202291
    Device Name
    Button Loop
    Manufacturer
    Yunyi (Beijing) Medical Device Co., Ltd.
    Date Cleared
    2021-01-08

    (149 days)

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

    Yunyi (Beijing) Medical Device Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Button Loop is used for the fixation of soft tissue to bone in orthopedic procedures such as ACL repair.
    Device Description
    The proposed device, Button Loop is a machined titanium implant designed to provide fixation in the repair of tendons and ligaments. It consists of a titanium implantable button with a pre-attached loop. This implantable loop has non-absorbable suture attached to the button for assisting in the button placement and is discarded after the device placement. The button is offered in 12mm one size and loop is available in size ranges of 10~60mm in 5mm increments to accommodate different graft sizes.
    Ask a Question

    Page 1 of 1