510(k) K081060

FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 by Core Essence Orthopaedics, LLC — Product Code GAQ

K081060 is an FDA 510(k) premarket notification submitted by Core Essence Orthopaedics, LLC for the device "FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5". The FDA issued a decision of Substantially Equivalent on December 24, 2008. The device falls under product code GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile), a Class II device regulated under 21 CFR 878.4495. Core Essence Orthopaedics, LLC has at least 5 other 510(k) clearances on record.