510(k) K964924

OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTENSION) by Osteoimplant Technology, Inc. — Product Code LPH

K964924 is an FDA 510(k) premarket notification submitted by Osteoimplant Technology, Inc. for the device "OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTENSION)". The FDA issued a decision of Substantially Equivalent on March 7, 1997. 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. Osteoimplant Technology, Inc. has at least 10 other 510(k) clearances on record.