510(k) K042344

EXCIA TOTAL HIP SYSTEM by Aesculap, Inc. — Product Code LWJ

K042344 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "EXCIA TOTAL HIP SYSTEM". The FDA issued a decision of Substantially Equivalent on March 16, 2005. The device falls under product code LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3360. Aesculap, Inc. has at least 10 other 510(k) clearances on record.