510(k) K121835

DOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATELLA WITH VE by Encore Medical L.P. — Product Code JWH

K121835 is an FDA 510(k) premarket notification submitted by Encore Medical L.P. for the device "DOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATELLA WITH VE". The FDA issued a decision of Substantially Equivalent on Jul 20, 2012. 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. Encore Medical L.P. has 81 other 510(k) clearances on record.