510(k) K933995

TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION by Applied Osteo Systems, Inc. — Product Code HSB

K933995 is an FDA 510(k) premarket notification submitted by Applied Osteo Systems, Inc. for the device "TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION". The FDA issued a decision of Substantially Equivalent on January 27, 1995. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Applied Osteo Systems, Inc. has at least 10 other 510(k) clearances on record.