510(k) K163311

GMK Revision Femoral Distal Augmentation by Medacta International S.A. — Product Code KRO

K163311 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "GMK Revision Femoral Distal Augmentation". The FDA issued a decision of Substantially Equivalent on December 21, 2016. The device falls under product code KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3510. Medacta International S.A. has at least 10 other 510(k) clearances on record.