510(k) K130279

REFORM PEDICLE SCREW SYSTEM by Spinal USA — Product Code MNI

K130279 is an FDA 510(k) premarket notification submitted by Spinal USA for the device "REFORM PEDICLE SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on June 20, 2013. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Spinal USA has at least 10 other 510(k) clearances on record.