510(k) K896204

ZIRCONIA CERAMIC HEAD ADD'L SIZES by Richards Medical Co., Inc. — Product Code LZO

K896204 is an FDA 510(k) premarket notification submitted by Richards Medical Co., Inc. for the device "ZIRCONIA CERAMIC HEAD ADD'L SIZES". The FDA issued a decision of SN on November 20, 1989. 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. Richards Medical Co., Inc. has at least 10 other 510(k) clearances on record.