510(k) K251720

OsteoFlo HydroFiber by SurGenTec, LLC — Product Code MQV

K251720 is an FDA 510(k) premarket notification submitted by SurGenTec, LLC for the device "OsteoFlo HydroFiber". The FDA issued a decision of Substantially Equivalent on July 2, 2025. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. SurGenTec, LLC has at least 10 other 510(k) clearances on record.