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.
?
Frequently Asked Questions
What materials are used for the suture anchors?
The anchors are manufactured from high-quality Ti6Al4V alloy, ensuring biocompatibility and strength according to ISO5832-3:2016 standards.
What is the composition of the suture?
The sutures are made of ultra-high molecular weight polyethylene (UHMWPE), providing exceptional tensile strength for orthopedic repairs.
Is the product supplied sterile?
Yes, all suture anchor systems are provided EO (Ethylene Oxide) Sterile and are ready for surgical use.
What certifications does this system hold?
Our Suture Anchor Systems are CE and ISO certified, meeting international medical device quality and safety requirements.
How is the product packaged for transport?
The items are securely packaged in a professional blister box followed by a secondary protective box to ensure integrity during shipping.
Is OEM service available?
Yes, we provide OEM services to meet specific requirements and branding needs for our global partners.
Nipa Orthopedic Implants
