510(k) K090103

100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL by Biomet, Inc. — Product Code MAY

K090103 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL". The FDA issued a decision of Substantially Equivalent on February 11, 2009. The device falls under product code MAY (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish), a Class II device regulated under 21 CFR 888.3353. Biomet, Inc. has at least 10 other 510(k) clearances on record.