510(k) K081227

PLEXUR M by Osteotech, Inc. — Product Code MQV

K081227 is an FDA 510(k) premarket notification submitted by Osteotech, Inc. for the device "PLEXUR M". The FDA issued a decision of Substantially Equivalent on July 22, 2008. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Osteotech, Inc. has at least 10 other 510(k) clearances on record.