510(k) K171004

Hintermann Series H2 Total Ankle System by Dt Medtech, LLC — Product Code HSN

K171004 is an FDA 510(k) premarket notification submitted by Dt Medtech, LLC for the device "Hintermann Series H2 Total Ankle System". The FDA issued a decision of Substantially Equivalent on November 7, 2017. The device falls under product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3110.