510(k) K834035

UNIVERSAL SELF-ALIGNING ACETABULAR COM by Orthopedic Equipment Co., Inc. — Product Code JDI

K834035 is an FDA 510(k) premarket notification submitted by Orthopedic Equipment Co., Inc. for the device "UNIVERSAL SELF-ALIGNING ACETABULAR COM". The FDA issued a decision of Substantially Equivalent on June 19, 1984. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Orthopedic Equipment Co., Inc. has at least 10 other 510(k) clearances on record.