510(k) K993259

INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS by Sulzer Orthopedics, Inc. — Product Code LPH

K993259 is an FDA 510(k) premarket notification submitted by Sulzer Orthopedics, Inc. for the device "INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS". The FDA issued a decision of Substantially Equivalent on March 10, 2000. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Sulzer Orthopedics, Inc. has at least 10 other 510(k) clearances on record.