510(k) K952271

GENESIS CONSTRAINED SYSTEM (GCS) by Smith & Nephew Richards, Inc. — Product Code JWH

K952271 is an FDA 510(k) premarket notification submitted by Smith & Nephew Richards, Inc. for the device "GENESIS CONSTRAINED SYSTEM (GCS)". The FDA issued a decision of Substantially Equivalent on September 8, 1995. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Smith & Nephew Richards, Inc. has at least 10 other 510(k) clearances on record.