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 made of high-strength Ti6Al4V alloy (ISO5832-3), and the suture consists of Ultra High Molecular Weight Polyethylene (UHMWPE) which meets ASTM F2848-17 standards.
Is the product provided sterile?
Yes, the system is EO (Ethylene Oxide) sterilized and packaged in a blister box to ensure safety for orthopedic surgery.
What is the intended clinical usage of this system?
It is specifically designed for orthopedic surgeries to connect soft tissue and bone, commonly used in sports medicine for rotator cuff or elbow repairs.
What certifications does the product hold?
The Suture Anchor System is CE and ISO13485 certified, complying with international medical device quality requirements.
Do you offer OEM services?
Yes, OEM services are available for this product based on specific requirements.
What is the warranty period for this implant?
The product comes with a 3-year warranty from the date of manufacture.
Alur Orthopedic Implants
