510(k) K931960

NUFFIELD TOTAL KNEE by Turnkey Intergration USA, Inc. — Product Code JWH

K931960 is an FDA 510(k) premarket notification submitted by Turnkey Intergration USA, Inc. for the device "NUFFIELD TOTAL KNEE". The FDA issued a decision of SN on October 7, 1994. 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. Turnkey Intergration USA, Inc. has at least 10 other 510(k) clearances on record.