510(k) K101976

INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET by Omni Life Science, Inc. — Product Code LPH

K101976 is an FDA 510(k) premarket notification submitted by Omni Life Science, Inc. for the device "INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET". The FDA issued a decision of Substantially Equivalent on September 14, 2010. 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. Omni Life Science, Inc. has at least 10 other 510(k) clearances on record.