510(k) K902264

TRUE/FLEX HUMERUS, ULNA AND RADIUS INTRAMEDULLARY by Applied Osteo Systems, Inc. — Product Code HSB

K902264 is an FDA 510(k) premarket notification submitted by Applied Osteo Systems, Inc. for the device "TRUE/FLEX HUMERUS, ULNA AND RADIUS INTRAMEDULLARY". The FDA issued a decision of Substantially Equivalent on July 12, 1990. 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.