510(k) K970846

22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD by Landos, Inc. — Product Code LZO

K970846 is an FDA 510(k) premarket notification submitted by Landos, Inc. for the device "22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD". The FDA issued a decision of SN on June 5, 1997. 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. Landos, Inc. has at least 10 other 510(k) clearances on record.