510(k) K111716

KNOTLESS SUTURE FIXATION SYSTEM by Core Essence Orthopaedics — Product Code MBI

K111716 is an FDA 510(k) premarket notification submitted by Core Essence Orthopaedics for the device "KNOTLESS SUTURE FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on November 10, 2011. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Core Essence Orthopaedics has at least 5 other 510(k) clearances on record.