510(k) K983339

OSTEO DYNATROC PROXIMAL FEMORAL NAIL by Osteonics Corp. — Product Code HSB

K983339 is an FDA 510(k) premarket notification submitted by Osteonics Corp. for the device "OSTEO DYNATROC PROXIMAL FEMORAL NAIL". The FDA issued a decision of Substantially Equivalent on October 27, 1998. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Osteonics Corp. has at least 10 other 510(k) clearances on record.