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 in the Suture Anchor System?
The anchor is constructed from high-strength Ti6Al4V titanium alloy, and the sutures are made from Ultra High Molecular Weight Polyethylene (UHMWPE) for maximum durability and safety.
Is the product provided in a sterile condition?
Yes, the suture anchors are EO (Ethylene Oxide) sterilized and packaged in professional blister boxes to ensure clinical safety.
What certifications do these orthopedic anchors hold?
Our products are fully compliant with CE and ISO standards, ensuring they meet international quality requirements for medical devices.
Can I request a sample before placing a bulk order?
Yes, samples can be provided for evaluation. Please contact our support team to discuss your specific clinical needs.
What is the shelf life and warranty for this system?
The suture anchor system comes with a 3-year warranty and is designed to maintain its integrity throughout its specified shelf life when stored correctly.
Is OEM customization available for this product?
Yes, OEM services are available to meet various surgical requirements and specifications.
Tonk Orthopedic Implants
