510(k) K123521

RELIANCE SPINAL SCREW SYSTEM by Reliance Medical Systems, LLC — Product Code MNI

K123521 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 Feb 7, 2013. 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.