510(k) K101126

PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS by Core Essence Orthopaedics, Inc. — Product Code MBI

K101126 is an FDA 510(k) premarket notification submitted by Core Essence Orthopaedics, Inc. for the device "PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS". The FDA issued a decision of Substantially Equivalent on December 2, 2010. 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, Inc. has at least 5 other 510(k) clearances on record.