About This 510(k) Submission
K081060 is an FDA 510(k) clearance for the FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5, a Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (Class II — Special Controls, product code GAQ), submitted by Core Essence Orthopaedics, LLC (Yardley, US). The FDA issued a Cleared decision on December 24, 2008, 254 days after receiving the submission on April 14, 2008. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4495.