510(k) K161447

HydroSet XT by Orthovita, Inc. — Product Code MQV

K161447 is an FDA 510(k) premarket notification submitted by Orthovita, Inc. for the device "HydroSet XT". The FDA issued a decision of Substantially Equivalent on October 6, 2016. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Orthovita, Inc. has at least 10 other 510(k) clearances on record.