510(k) K113409

S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL by Howmedica Osteonics Corp. — Product Code HSB

K113409 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. for the device "S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL". The FDA issued a decision of Substantially Equivalent on February 15, 2012. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Howmedica Osteonics Corp. has at least 10 other 510(k) clearances on record.