510(k) K984227

OMEGA II MODULAR TOTAL HIP SYSTEM by Osteoimplant Technology, Inc. — Product Code JDI

K984227 is an FDA 510(k) premarket notification submitted by Osteoimplant Technology, Inc. for the device "OMEGA II MODULAR TOTAL HIP SYSTEM". The FDA issued a decision of Substantially Equivalent on April 8, 1999. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Osteoimplant Technology, Inc. has at least 10 other 510(k) clearances on record.