510(k) K181635

GMK Sphere CR Tibial Inserts by Medacta International S.A. — Product Code JWH

K181635 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "GMK Sphere CR Tibial Inserts". The FDA issued a decision of Substantially Equivalent on Aug 23, 2018. 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. Medacta International S.A. has 207 other 510(k) clearances on record.