510(k) K983419

HOFFMANN II MIAMI POST by Howmedica Corp. — Product Code HRS

K983419 is an FDA 510(k) premarket notification submitted by Howmedica Corp. for the device "HOFFMANN II MIAMI POST". The FDA issued a decision of Substantially Equivalent on November 25, 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.