510(k) K952629

NEXFLEX TOTAL HIP SYSTEM by Nexmed, Inc. — Product Code JDI

K952629 is an FDA 510(k) premarket notification submitted by Nexmed, Inc. for the device "NEXFLEX TOTAL HIP SYSTEM". The FDA issued a decision of Substantially Equivalent on September 8, 1995. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Nexmed, Inc. has at least 5 other 510(k) clearances on record.