510(k) K162066

Reliance Spinal Screw System by Reliance Medical Systems, LLC — Product Code MNH

K162066 is an FDA 510(k) premarket notification submitted by Reliance Medical Systems, LLC for the device "Reliance Spinal Screw System". The FDA issued a decision of Substantially Equivalent on December 2, 2016. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Reliance Medical Systems, LLC has at least 10 other 510(k) clearances on record.