510(k) K173301

BioSphere MIS Putty (BioSphere MIS) by Synergy Biomedical, LLC — Product Code MQV

K173301 is an FDA 510(k) premarket notification submitted by Synergy Biomedical, LLC for the device "BioSphere MIS Putty (BioSphere MIS)". The FDA issued a decision of Substantially Equivalent on January 19, 2018. 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.