510(k) K151695

Romeo posterior osteosynthesis system by Spineart — Product Code MNH

K151695 is an FDA 510(k) premarket notification submitted by Spineart for the device "Romeo posterior osteosynthesis system". The FDA issued a decision of Substantially Equivalent on September 10, 2015. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Spineart has at least 10 other 510(k) clearances on record.