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510(k) Data Aggregation

    K Number
    K202291
    Device Name
    Button Loop
    Date Cleared
    2021-01-08

    (149 days)

    Product Code
    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 AuthorizedThirdparty
    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.
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    K Number
    K192637
    Device Name
    High Strength Suture
    Date Cleared
    2020-03-02

    (160 days)

    Product Code
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Yunyi (Beijing) Medical Device Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is indicated for use in general soft tissue approximation and/or ligation, including use in allograft tissues for orthopedic procedures
    Device Description
    The proposed device is a braided synthetic, non-absorbable surgical suture made of ultra-high molecular weight polyethylene and medical adhesive at both ends of the suture. The proposed device is undyed and uncoated. The sutures are available in a range of sizes. The device does not contain needle. And the device is provided in sterile.
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