510(k) K191380

Quantum® Total Ankle Prosthesis by In2bones Sas — Product Code HSN

K191380 is an FDA 510(k) premarket notification submitted by In2bones Sas for the device "Quantum® Total Ankle Prosthesis". The FDA issued a decision of Substantially Equivalent on January 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. In2bones Sas has at least 10 other 510(k) clearances on record.