510(k) K150294

DPZ Pedicular Fixation System by Osteomed Implantes, Ltda — Product Code MNI

K150294 is an FDA 510(k) premarket notification submitted by Osteomed Implantes, Ltda for the device "DPZ Pedicular Fixation System". The FDA issued a decision of Substantially Equivalent on Jun 5, 2015. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Osteomed Implantes, Ltda has at least 2 other 510(k) clearances on record.