510(k) K150049

PASS LP Spinal System by Medicrea International — Product Code MNI

K150049 is an FDA 510(k) premarket notification submitted by Medicrea International for the device "PASS LP Spinal System". The FDA issued a decision of Substantially Equivalent on Feb 10, 2015. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Medicrea International has at least 10 other 510(k) clearances on record.