510(k) K103233

MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT by Howmedica Osteonics Corp. — Product Code LZO

K103233 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. for the device "MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT". The FDA issued a decision of Substantially Equivalent on February 3, 2011. 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 Osteonics Corp. has at least 10 other 510(k) clearances on record.