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, approved by FDA. Part of inserter contacting human body is made of stainless steel conforming ASTM F899-12b. Handle of inserter is made of polycarbonate and ABS material.
Frequently Asked Questions
What materials are used for the Suture Anchor?
The anchor is constructed from high-quality Ti6Al4V alloy, while the suture is made from ultra-high molecular weight polyethylene (UHMWPE), ensuring high strength and biocompatibility.
Is the product sterilized before shipping?
Yes, the suture anchor systems are EO (Ethylene Oxide) sterilized and packaged in sterile blister boxes to ensure safety for surgical use.
What certifications does the WZ-MDT model hold?
This product is fully certified with CE and ISO13485 standards, meeting international requirements for medical implants.
Can the handle of the inserter be used in direct contact with patients?
No, the handle is designed for the surgeon's grip and is made of polycarbonate and ABS. Only the stainless steel part of the inserter is designed for potential human body contact during the procedure.
Is OEM service available for this system?
Yes, OEM services are available to meet specific professional requirements and branding needs.
What is the warranty period for this medical device?
The Suture Anchor System comes with a 3-year warranty, reflecting its durability and manufacturing quality.
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