510(k) K001536

INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS by Sulzer Orthopedics, Inc. — Product Code KWA

K001536 is an FDA 510(k) premarket notification submitted by Sulzer Orthopedics, Inc. for the device "INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS". The FDA issued a decision of Substantially Equivalent on July 27, 2000. 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.