510(k) K853730

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

K853730 is an FDA 510(k) premarket notification submitted by Protek, Inc. for the device "FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP". The FDA issued a decision of Substantially Equivalent on February 18, 1986. 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.