510(k) K033944

STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD by Stelkast Company — Product Code LZO

K033944 is an FDA 510(k) premarket notification submitted by Stelkast Company for the device "STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD". The FDA issued a decision of Substantially Equivalent on March 12, 2004. 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. Stelkast Company has at least 10 other 510(k) clearances on record.