510(k) K170573

Empowr CR Knee Tibial Insert by Encore Medical L.P. — Product Code JWH

K170573 is an FDA 510(k) premarket notification submitted by Encore Medical L.P. for the device "Empowr CR Knee Tibial Insert". The FDA issued a decision of Substantially Equivalent on May 31, 2017. 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 80 other 510(k) clearances on record.