510(k) K140844

BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC by Synergy Biomedical, Inc. — Product Code MQV

K140844 is an FDA 510(k) premarket notification submitted by Synergy Biomedical, Inc. for the device "BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC". The FDA issued a decision of Substantially Equivalent on July 16, 2014. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Synergy Biomedical, Inc. has at least 4 other 510(k) clearances on record.