510(k) K191449

ZCA All-Poly Acetabular Cups by Zimmer, Inc. — Product Code JDI

K191449 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "ZCA All-Poly Acetabular Cups". The FDA issued a decision of Substantially Equivalent on July 16, 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.