510(k) K241167

BioSphere Putty; BioSphere MIS Putty by Synergy Biomedical — Product Code MQV

K241167 is an FDA 510(k) premarket notification submitted by Synergy Biomedical for the device "BioSphere Putty; BioSphere MIS Putty". The FDA issued a decision of Substantially Equivalent on December 20, 2024. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Synergy Biomedical has at least 4 other 510(k) clearances on record.