510(k) K873429

FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE by Protek, Inc. — Product Code MBV

K873429 is an FDA 510(k) premarket notification submitted by Protek, Inc. for the device "FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE". The FDA issued a decision of Substantially Equivalent on October 28, 1987. 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. Protek, Inc. has at least 10 other 510(k) clearances on record.