510(k) K172189

Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt by Truemed Group, LLC — Product Code HSB

K172189 is an FDA 510(k) premarket notification submitted by Truemed Group, LLC for the device "Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt". The FDA issued a decision of Substantially Equivalent on Jan 16, 2018. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Truemed Group, LLC has 4 other 510(k) clearances on record.