510(k) K003758

ALLOFIT ACETABULAR SYSTEM by Sulzer Orthopedics, Inc. — Product Code KWA

K003758 is an FDA 510(k) premarket notification submitted by Sulzer Orthopedics, Inc. for the device "ALLOFIT ACETABULAR SYSTEM". The FDA issued a decision of Substantially Equivalent on March 7, 2001. The device falls under product code KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)), a Class III device regulated under 21 CFR 888.3330. Sulzer Orthopedics, Inc. has at least 10 other 510(k) clearances on record.