510(k) K982531

HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM by Howmedica Corp. — Product Code HRS

K982531 is an FDA 510(k) premarket notification submitted by Howmedica Corp. for the device "HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on October 16, 1998. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Howmedica Corp. has at least 10 other 510(k) clearances on record.