510(k) K171568

SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty by Hans Biomed Corporation — Product Code MQV

K171568 is an FDA 510(k) premarket notification submitted by Hans Biomed Corporation for the device "SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty". The FDA issued a decision of Substantially Equivalent on February 22, 2018. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Hans Biomed Corporation has at least 3 other 510(k) clearances on record.