510(k) K854465

LINK CONTOUR RIBBED HIP PROSTHESES SYSTEM by Link America, Inc. — Product Code JDI

K854465 is an FDA 510(k) premarket notification submitted by Link America, Inc. for the device "LINK CONTOUR RIBBED HIP PROSTHESES SYSTEM". The FDA issued a decision of Substantially Equivalent on February 10, 1986. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Link America, Inc. has at least 10 other 510(k) clearances on record.