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Product Description
Suture Anchor Titanium Orthopedic Instrument Superior Quality Implantation Equipment 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.
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Frequently Asked Questions
What material is the Suture Anchor made of?
The anchor is constructed from high-quality Ti6Al4V titanium alloy, adhering to ISO5832-3:2016 standards for medical implantation.
Is the suture anchor system supplied sterile?
Yes, the system is EO (Ethylene Oxide) sterilized and packaged in a blister box to ensure safety and clinical readiness.
What are the primary applications for this device?
It is specifically designed for orthopedic surgery to effectively connect soft tissue to bone during reconstructive procedures.
What certifications does the product have?
The product is fully certified with CE and ISO13485, meeting international quality and safety requirements for medical devices.
Do you offer OEM services?
Yes, OEM services are available to meet specific requirements and professional branding needs.
What is the warranty period for this instrument?
The Suture Anchor System comes with a 3-year warranty covering manufacturing standards and material integrity.
XOVEC Orthopedic Implants
