510(k) K100555

APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK by Omni Life Science, Inc. — Product Code LPH

K100555 is an FDA 510(k) premarket notification submitted by Omni Life Science, Inc. for the device "APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK". The FDA issued a decision of Substantially Equivalent on March 29, 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.