510(k) K982602

RETROGRADE ROD SYSTEM by Howmedica Corp. — Product Code HSB

K982602 is an FDA 510(k) premarket notification submitted by Howmedica Corp. for the device "RETROGRADE ROD SYSTEM". The FDA issued a decision of Substantially Equivalent on September 14, 1998. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Howmedica Corp. has at least 10 other 510(k) clearances on record.