510(k) K071520

RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X by Core Essence Orthopaedics, LLC — Product Code MBI

K071520 is an FDA 510(k) premarket notification submitted by Core Essence Orthopaedics, LLC for the device "RENOVO SUTURE ANCHORS, MODELS 100-2001 THRU 100-5502X". The FDA issued a decision of Substantially Equivalent on August 10, 2007. 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, LLC has at least 5 other 510(k) clearances on record.