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-grade Ti6Al4V titanium alloy, while the suture is made of Ultra High Molecular Weight Polyethylene (UHMWPE) for superior strength and biocompatibility.
Are your orthopedic products internationally certified?
Yes, all products are fully compliant with CE certification and ISO 13485 standards, ensuring they meet global medical safety and quality benchmarks.
What is the intended clinical usage of this device?
The system is specifically designed for orthopedic surgeries to securely connect soft tissue to bone, such as in joint repair procedures.
Do you provide OEM and customized packaging services?
Yes, we offer comprehensive OEM services, including custom designs and professional blister box packaging to meet specific branding and clinical requirements.
What is the shelf life and warranty of the product?
The products are provided EO Sterile and come with a 3-year warranty from the date of manufacture.
Can I request a sample for quality evaluation?
Samples can be provided for evaluation. Please contact our technical team to discuss specific size requirements and delivery timelines.
Grai Orthopedic Implants
