510(k) K122868

BIOSPHERE BIOACTIVE BONE GRAFT PUTTY by Synergy Biomedical, LLC — Product Code MQV

K122868 is an FDA 510(k) premarket notification submitted by Synergy Biomedical, LLC for the device "BIOSPHERE BIOACTIVE BONE GRAFT PUTTY". The FDA issued a decision of Substantially Equivalent on April 19, 2013. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Synergy Biomedical, LLC has at least 4 other 510(k) clearances on record.