510(k) K982068

HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM by Howmedica Corp. — Product Code JDW

K982068 is an FDA 510(k) premarket notification submitted by Howmedica Corp. for the device "HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM". The FDA issued a decision of Substantially Equivalent on August 31, 1998. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040. Howmedica Corp. has at least 10 other 510(k) clearances on record.