510(k) K871347

WAGNER REVISIONAL FEMORAL HIP PROSTHESIS by Protek, Inc. — Product Code JDI

K871347 is an FDA 510(k) premarket notification submitted by Protek, Inc. for the device "WAGNER REVISIONAL FEMORAL HIP PROSTHESIS". The FDA issued a decision of Substantially Equivalent on July 1, 1987. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Protek, Inc. has at least 10 other 510(k) clearances on record.