510(k) K001078

SULZER ORTHOPEDICS MS-30 FEMORAL STEM by Sulzer Orthopedics, Inc. — Product Code JDI

K001078 is an FDA 510(k) premarket notification submitted by Sulzer Orthopedics, Inc. for the device "SULZER ORTHOPEDICS MS-30 FEMORAL STEM". The FDA issued a decision of Substantially Equivalent on June 23, 2000. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Sulzer Orthopedics, Inc. has at least 10 other 510(k) clearances on record.