510(k) K003832

SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM by Sulzer Orthopedics, Inc. — Product Code KWS

K003832 is an FDA 510(k) premarket notification submitted by Sulzer Orthopedics, Inc. for the device "SULZER ORTHOPEDICS ANATOMICAL SHOULDER CEMENTED HUMERAL STEM". The FDA issued a decision of Substantially Equivalent on January 4, 2001. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Sulzer Orthopedics, Inc. has at least 10 other 510(k) clearances on record.