510(k) K191393

INFINITY Total Ankle System, INBONE Total Ankle System by Wrightmedicaltechnologyinc — Product Code HSN

K191393 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "INFINITY Total Ankle System, INBONE Total Ankle System". The FDA issued a decision of Substantially Equivalent on August 22, 2019. The device falls under product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3110. Wrightmedicaltechnologyinc has at least 10 other 510(k) clearances on record.