510(k) K201507

Cadence Total Ankle System by Integra LifeSciences Corporation — Product Code HSN

K201507 is an FDA 510(k) premarket notification submitted by Integra LifeSciences Corporation for the device "Cadence Total Ankle System". The FDA issued a decision of Substantially Equivalent on June 29, 2020. The device falls under product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3110. Integra LifeSciences Corporation has at least 10 other 510(k) clearances on record.