510(k) K082468

APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60) by Omni Life Science, Inc. — Product Code KWY

K082468 is an FDA 510(k) premarket notification submitted by Omni Life Science, Inc. for the device "APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)". The FDA issued a decision of Substantially Equivalent on February 18, 2009. The device falls under product code KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented), a Class II device regulated under 21 CFR 888.3390. Omni Life Science, Inc. has at least 10 other 510(k) clearances on record.