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510(k) Data Aggregation
K Number
K202291Device Name
Button Loop
Manufacturer
Date Cleared
2021-01-08
(149 days)
Product Code
Regulation Number
888.3040Why 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
K192637Device Name
High Strength Suture
Manufacturer
Date Cleared
2020-03-02
(160 days)
Product Code
Regulation Number
878.5000Why 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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