510(k) K083566

R3 CONSTRAINED LINER, CONSTRAINED LINER by Smith & Nephew, Inc. — Product Code KWZ

K083566 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "R3 CONSTRAINED LINER, CONSTRAINED LINER". The FDA issued a decision of Substantially Equivalent on March 3, 2009. The device falls under product code KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3310. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.