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Product Description
Suture Anchor System consists of anchor, nonabsorbable suture and inserter. Anchor is made of Ti6Al4V alloy, which meets the requirement of ISO5832-3:2016. Suture is made of ultra high molecular weight polyethylene material without coating, it is woven from several UHMWPE yarn, which meets the requirement of ASTM F2848-17. Blue suture is from white ultra high molecular weight polyethylene, dyed with blue color material, code of blue material is 73.1015, which listed and approved by FDA. Part of inserter contacting human body is made of stainless steel conforming ASTM F899-12b. Handle of inserter will not contact human body, and it is made of polycarbonate and ABS material.
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Frequently Asked Questions
What materials are used for the Suture Anchor?
The anchor is constructed from high-quality Ti6Al4V alloy, which complies with ISO5832-3:2016 standards for surgical implants.
Is the suture material safe and approved?
Yes, the suture is made from ultra-high molecular weight polyethylene (UHMWPE) woven yarn. The blue coloring material is FDA listed and approved.
What certifications does the product hold?
The Suture Anchor System is fully certified with CE and ISO13485, ensuring it meets international medical device standards.
How is the product sterilized?
The system is provided EO (Ethylene Oxide) Sterile, making it ready for immediate use in orthopedic surgery.
What is the warranty and shelf life for this system?
We provide a 3-year warranty for the Suture Anchor System, reflecting its durability and manufacturing quality.
What is the primary surgical function of this device?
Its primary function is to securely connect soft tissue to bone during orthopedic procedures, commonly used in rotator cuff and elbow repairs.
XOVEC Orthopedic Implants
