510(k) K110547

OPTERTRAK LOGIC PSC TIBIAL INSERT by Exactech Sarasota — Product Code JWH

K110547 is an FDA 510(k) premarket notification submitted by Exactech Sarasota for the device "OPTERTRAK LOGIC PSC TIBIAL INSERT". The FDA issued a decision of Substantially Equivalent on Apr 14, 2011. 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. Exactech Sarasota has at least 1 other 510(k) clearance on record.