510(k) K150647

Polyscrew Pedicle Screw System by New Era Orthopedics, LLC — Product Code MNI

K150647 is an FDA 510(k) premarket notification submitted by New Era Orthopedics, LLC for the device "Polyscrew Pedicle Screw System". The FDA issued a decision of Substantially Equivalent on April 8, 2015. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. New Era Orthopedics, LLC has at least 1 other 510(k) clearance on record.