510(k) K071477

REVERTO 55 AND 37 SHAPE MEMORY STAPLES by Core Essence Orthopaedics, LLC — Product Code JDR

K071477 is an FDA 510(k) premarket notification submitted by Core Essence Orthopaedics, LLC for the device "REVERTO 55 AND 37 SHAPE MEMORY STAPLES". The FDA issued a decision of Substantially Equivalent on August 15, 2007. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Core Essence Orthopaedics, LLC has at least 5 other 510(k) clearances on record.