510(k) K200823

Zimmer, Inc. Hip Joint Prostheses MR Labeling I by Zimmer, Inc. — Product Code JDI

K200823 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "Zimmer, Inc. Hip Joint Prostheses MR Labeling I". The FDA issued a decision of Substantially Equivalent on July 9, 2020. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Zimmer, Inc. has at least 10 other 510(k) clearances on record.