510(k) K010241

PROTRACT PRESS FIT HIP STEM-HA COATED by Stelkast Company — Product Code LPH

K010241 is an FDA 510(k) premarket notification submitted by Stelkast Company for the device "PROTRACT PRESS FIT HIP STEM-HA COATED". The FDA issued a decision of Substantially Equivalent on February 8, 2001. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Stelkast Company has at least 10 other 510(k) clearances on record.