510(k) K954219

REALITY LONG STEM HIP SYSTEM by Kinamed, Inc. — Product Code JDI

K954219 is an FDA 510(k) premarket notification submitted by Kinamed, Inc. for the device "REALITY LONG STEM HIP SYSTEM". The FDA issued a decision of Substantially Equivalent on December 4, 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. Kinamed, Inc. has at least 10 other 510(k) clearances on record.