510(k) K011954

SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE by Sulzer Orthopedics, Inc. — Product Code HSX

K011954 is an FDA 510(k) premarket notification submitted by Sulzer Orthopedics, Inc. for the device "SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE". The FDA issued a decision of Substantially Equivalent on September 19, 2001. The device falls under product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3520. Sulzer Orthopedics, Inc. has at least 10 other 510(k) clearances on record.