510(k) K935383

FEMROD AND FEMROD RECON INSERT by Applied Osteo Systems, Inc. — Product Code HSB

K935383 is an FDA 510(k) premarket notification submitted by Applied Osteo Systems, Inc. for the device "FEMROD AND FEMROD RECON INSERT". The FDA issued a decision of Substantially Equivalent on March 21, 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.