510(k) K153273

MySpine Pedicle Screw Placement Guides - LP by Medacta International S.A. — Product Code MNI

K153273 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "MySpine Pedicle Screw Placement Guides - LP". The FDA issued a decision of Substantially Equivalent on June 29, 2016. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Medacta International S.A. has at least 10 other 510(k) clearances on record.