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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 in the Suture Anchor System?
The anchor is constructed from high-quality Ti6Al4V titanium alloy, meeting ISO5832-3:2016 standards. The suture is made from ultra-high molecular weight polyethylene (UHMWPE).
Is the product provided in a sterile condition?
Yes, the suture anchor system is EO (Ethylene Oxide) sterilized and individually packed in sterile blister boxes for immediate surgical use.
What certifications does this implant hold?
The product is fully certified with CE and ISO13485, ensuring it meets international quality and safety requirements for medical devices.
What are the primary applications for this device?
It is primarily used in orthopedic surgery, specifically for shoulder arthroscopy and other procedures requiring the connection of soft tissue to bone.
What is the warranty period for the system?
The system typically comes with a warranty of up to 3 years, reflecting its high durability and manufacturing standards.
Can I request a sample before bulk ordering?
Yes, samples can be provided for evaluation purposes to ensure the specifications meet your surgical requirements.