510(k) K934161

PROFORM HIP SYSTEM by Stelkast Company — Product Code JDO

K934161 is an FDA 510(k) premarket notification submitted by Stelkast Company for the device "PROFORM HIP SYSTEM". The FDA issued a decision of Substantially Equivalent on March 10, 1994. The device falls under product code JDO (Device, Fixation, Proximal Femoral, Implant), a Class II device regulated under 21 CFR 888.3030. Stelkast Company has at least 10 other 510(k) clearances on record.