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FDA 510(k)

Vantage® Total Ankle System

K-Number: K232002 · 2023-09-11

ApplicantExactech, Inc.
Decision Date2023-09-11
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Vantage® Total Ankle System is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2023-09-11 under approval number K232002. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vantage® Total Ankle System?

Vantage® Total Ankle System is a medical device that received FDA 510(k) clearance on 2023-09-11. It is manufactured by Exactech, Inc.. The 510(k) number is K232002.

When was Vantage® Total Ankle System approved by the FDA?

Vantage® Total Ankle System received FDA 510(k) clearance on 2023-09-11, under approval number K232002.

What company makes Vantage® Total Ankle System?

Vantage® Total Ankle System is manufactured by Exactech, Inc..

What is the FDA product code for Vantage® Total Ankle System?

The FDA product code for Vantage® Total Ankle System is HSN.

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Related PubMed Literature

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Other Devices by Exactech, Inc.

K153649Exactech® Novation® Element Press-fit Femoral Stem K160697Gibralt® Spine System and Gibralt® Occipital Spine System K153595Optetrak Logic Metaphyseal Cones K160484Optetrak Advanced Patella K152217Exactech Vantage Total Ankle System K153776Optetrak One Logic Femoral Components

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Related Devices (Code: HSN)

K153452Salto XT, Salto TalarisTornier S.A.S. K153008INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc K152217Exactech Vantage Total Ankle SystemExactech, Inc. K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC K171067INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc K170968PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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