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The Suture Anchor System consists of an anchor, nonabsorbable suture, and inserter. The anchor is manufactured from Ti6Al4V alloy, conforming to ISO5832-3:2016 standards. The suture is crafted from ultra-high molecular weight polyethylene (UHMWPE) material without coating, woven from multiple UHMWPE yarns in compliance with ASTM F2848-17. The blue suture is derived from white UHMWPE dyed with FDA-approved blue material (code 73.1015). The stainless steel portion of the inserter that contacts the human body conforms to ASTM F899-12b, while the handle is constructed from polycarbonate and ABS material.
Medev Medical