510(k) K890331

FREEMAN TOTAL HIP SYSTEM RIDGED STEM by Orthopedic Systems, Inc. — Product Code LWJ

K890331 is an FDA 510(k) premarket notification submitted by Orthopedic Systems, Inc. for the device "FREEMAN TOTAL HIP SYSTEM RIDGED STEM". The FDA issued a decision of Substantially Equivalent on October 13, 1989. The device falls under product code LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3360. Orthopedic Systems, Inc. has at least 10 other 510(k) clearances on record.