510(k) K142798

PASS LP Spinal System by Medicrea International SA — Product Code MNH

K142798 is an FDA 510(k) premarket notification submitted by Medicrea International SA for the device "PASS LP Spinal System". The FDA issued a decision of Substantially Equivalent on March 25, 2015. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Medicrea International SA has at least 10 other 510(k) clearances on record.