510(k) K100377

DIAMONDBACK SPINAL SYSTEM by Eminent Spine — Product Code MNI

K100377 is an FDA 510(k) premarket notification submitted by Eminent Spine for the device "DIAMONDBACK SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on April 22, 2010. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Eminent Spine has at least 10 other 510(k) clearances on record.