510(k) K972183

DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL by Ace Medical Co. — Product Code HSB

K972183 is an FDA 510(k) premarket notification submitted by Ace Medical Co. for the device "DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL". The FDA issued a decision of Substantially Equivalent on August 26, 1997. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Ace Medical Co. has at least 10 other 510(k) clearances on record.