510(k) K851341

SYNATOMIC VARIABLE FIT TIBIAL PLATEAU by Depuy, Inc. — Product Code KYK

K851341 is an FDA 510(k) premarket notification submitted by Depuy, Inc. for the device "SYNATOMIC VARIABLE FIT TIBIAL PLATEAU". The FDA issued a decision of Substantially Equivalent on July 15, 1985. The device falls under product code KYK (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite), a Class II device regulated under 21 CFR 888.3500. Depuy, Inc. has at least 10 other 510(k) clearances on record.