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 System?
The anchor is constructed from high-strength Ti6Al4V alloy (ISO5832-3:2016). The sutures are made of Ultra High Molecular Weight Polyethylene (UHMWPE) which meets ASTM F2848-17 standards.
Is the product certified for international medical use?
Yes, the system is fully certified with CE and ISO13485, ensuring it meets strict quality and safety requirements for orthopedic surgery.
How is the product sterilized?
The Suture Anchor System is provided EO (Ethylene Oxide) Sterile, ready for immediate use in clinical environments.
What is the primary application of this device?
It is primarily used in sports medicine and orthopedic surgery to securely connect soft tissues, such as tendons or ligaments, to the bone.
Does the product come with a warranty?
Yes, we provide a 3-year warranty for this product, reflecting our confidence in its durability and performance.
Is OEM customization available?
Yes, OEM services are available to meet specific requirements for different surgical needs and professional preferences.
Alur Orthopedic Implants
