510(k) K833200

TRICON M TOTAL KNEE SYSTEM by Richards Medical Co., Inc. — Product Code MBV

K833200 is an FDA 510(k) premarket notification submitted by Richards Medical Co., Inc. for the device "TRICON M TOTAL KNEE SYSTEM". The FDA issued a decision of Substantially Equivalent on November 29, 1983. The device falls under product code MBV (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Richards Medical Co., Inc. has at least 10 other 510(k) clearances on record.