510(k) K152131

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

K152131 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 Sep 17, 2015. The device falls under product code MNI (Orthosis, Spinal Pedicle 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.