510(k) K935696

ETEX HA HIP REPLACEMENT SYSTEM by Etex Corp. — Product Code MEH

K935696 is an FDA 510(k) premarket notification submitted by Etex Corp. for the device "ETEX HA HIP REPLACEMENT SYSTEM". The FDA issued a decision of SN on July 22, 1994. The device falls under product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate), a Class II device regulated under 21 CFR 888.3353. Etex Corp. has at least 10 other 510(k) clearances on record.