510(k) K183343

Vantage Total Ankle Flat Cut Talar Components by Exactech, Inc. — Product Code HSN

K183343 is an FDA 510(k) premarket notification submitted by Exactech, Inc. for the device "Vantage Total Ankle Flat Cut Talar Components". The FDA issued a decision of Substantially Equivalent on April 1, 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. Exactech, Inc. has at least 10 other 510(k) clearances on record.