510(k) K983404

TYPE 3 FEMORAL COMPONENTS by Howmedica Corp. — Product Code LZO

K983404 is an FDA 510(k) premarket notification submitted by Howmedica Corp. for the device "TYPE 3 FEMORAL COMPONENTS". The FDA issued a decision of Substantially Equivalent on December 22, 1998. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Howmedica Corp. has at least 10 other 510(k) clearances on record.