Reliable Suture Anchor System for Orthopedic Shoulder Procedures. The Peek Suture Anchor System consists of an anchor, nonabsorbable suture, and inserter. The anchor is made of high-strength Ti6Al4V alloy, meeting ISO5832-3:2016 requirements. The suture is crafted from ultra-high molecular weight polyethylene (UHMWPE) without coating, woven for maximum durability and meeting ASTM F2848-17 standards. The blue color indicator is FDA-approved material (code 73.1015). Surgical contact parts of the inserter are made of medical-grade stainless steel (ASTM F899-12b), while the ergonomic handle is constructed from polycarbonate and ABS material.
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Frequently Asked Questions
What materials are used for the anchor and suture?
The anchor is made of medical-grade Titanium Alloy (Ti6Al4V), and the suture is made of Ultra-High Molecular Weight Polyethylene (UHMWPE).
Is the suture anchor system sterile?
Yes, the product is provided EO (Ethylene Oxide) sterile in professional blister box packaging.
What clinical procedures is this system intended for?
It is primarily designed for orthopedic shoulder procedures to connect soft tissue and bone securely.
Does the product have international certifications?
Yes, the system is certified by CE and ISO13485, ensuring it meets global medical safety standards.
What is the warranty period for this medical device?
The product comes with a 3-year warranty period.
Are OEM services available for clinical requirements?
Yes, OEM customization is available to meet specific clinical and professional needs.
Medev Medical
