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FDA 510(k)

Vantage Total Ankle Flat Cut Talar Components

K-Number: K183343 · 2019-04-01

ApplicantExactech, Inc.
Decision Date2019-04-01
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Vantage Total Ankle Flat Cut Talar Components is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2019-04-01 under approval number K183343. 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 Flat Cut Talar Components?

Vantage Total Ankle Flat Cut Talar Components is a medical device that received FDA 510(k) clearance on 2019-04-01. It is manufactured by Exactech, Inc.. The 510(k) number is K183343.

When was Vantage Total Ankle Flat Cut Talar Components approved by the FDA?

Vantage Total Ankle Flat Cut Talar Components received FDA 510(k) clearance on 2019-04-01, under approval number K183343.

What company makes Vantage Total Ankle Flat Cut Talar Components?

Vantage Total Ankle Flat Cut Talar Components is manufactured by Exactech, Inc..

What is the FDA product code for Vantage Total Ankle Flat Cut Talar Components?

The FDA product code for Vantage Total Ankle Flat Cut Talar Components is HSN.

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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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