510(k) K151458

Double Medical Universal Spine System by Double Medical Technology, Inc. — Product Code MNI

K151458 is an FDA 510(k) premarket notification submitted by Double Medical Technology, Inc. for the device "Double Medical Universal Spine System". The FDA issued a decision of Substantially Equivalent on August 22, 2016. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Double Medical Technology, Inc. has at least 10 other 510(k) clearances on record.