510(k) K970897

BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM by Biodynamic Technologies, Inc. — Product Code HSB

K970897 is an FDA 510(k) premarket notification submitted by Biodynamic Technologies, Inc. for the device "BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM". The FDA issued a decision of Substantially Equivalent on April 21, 1997. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Biodynamic Technologies, Inc. has at least 10 other 510(k) clearances on record.