🔬 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.
❓ Frequently Asked Questions
What materials are used in the Suture Anchor System?
The anchor is constructed from high-quality Ti6Al4V Titanium alloy (ISO5832-3:2016), while the suture is made of ultra-high molecular weight polyethylene (UHMWPE) for superior strength and biocompatibility.
Is the product provided in a sterile condition?
Yes, all units are EO (Ethylene Oxide) sterile and come in professional sterile packaging (1pc per package) ready for surgical use.
What is the primary function of this anchor system?
The system is specifically designed for orthopedic surgery to securely connect soft tissue to bone, commonly used in procedures like shoulder arthroscopy.
Does the system meet international medical standards?
Absolutely. The product is Class II instrument classified and holds both CE and ISO13485 certifications, meeting stringent ASTM and ISO requirements.
What is the warranty period for the WZ-MDT model?
The Suture Anchor System comes with a 3-year warranty, ensuring long-term reliability and performance for orthopedic implants.
Can I request samples before placing a bulk order?
Yes, samples can be provided for evaluation purposes to ensure the product meets your specific clinical requirements.
DTRX Orthopedic Implants
