510(k) K161254

Renovo Life Small Bone IM Nail System by Renovo Life, LLC — Product Code HSB

K161254 is an FDA 510(k) premarket notification submitted by Renovo Life, LLC for the device "Renovo Life Small Bone IM Nail System". The FDA issued a decision of Substantially Equivalent on November 7, 2016. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Renovo Life, LLC has at least 1 other 510(k) clearance on record.