510(k) K090033

MODIFICATION TO: PSS SYSTEM by Spinal USA — Product Code MNI

K090033 is an FDA 510(k) premarket notification submitted by Spinal USA for the device "MODIFICATION TO: PSS SYSTEM". The FDA issued a decision of Substantially Equivalent on May 6, 2009. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Spinal USA has at least 10 other 510(k) clearances on record.