510(k) K143417

ANAX 5.5 Spinal System by U&I Corporation — Product Code MNH

K143417 is an FDA 510(k) premarket notification submitted by U&I Corporation for the device "ANAX 5.5 Spinal System". The FDA issued a decision of Substantially Equivalent on February 25, 2015. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. U&I Corporation has at least 10 other 510(k) clearances on record.