510(k) K201701

R3 HA Coated Acetabular Shells by Smith & Nephew, Inc. — Product Code MBL

K201701 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "R3 HA Coated Acetabular Shells". The FDA issued a decision of Substantially Equivalent on October 6, 2020. The device falls under product code MBL (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous), a Class II device regulated under 21 CFR 888.3358. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.