510(k) K983358

G/K SFN AND STN LOCKING NAILS by Howmedica, Inc. — Product Code HSB

K983358 is an FDA 510(k) premarket notification submitted by Howmedica, Inc. for the device "G/K SFN AND STN LOCKING NAILS". The FDA issued a decision of Substantially Equivalent on November 18, 1998. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Howmedica, Inc. has at least 10 other 510(k) clearances on record.