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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 the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2019-04-01 under 510(k) 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. The listed applicant is Exactech, Inc.. The 510(k) number is K183343.

When did Vantage Total Ankle Flat Cut Talar Components receive FDA 510(k) clearance?

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

Who is the listed applicant for Vantage Total Ankle Flat Cut Talar Components?

The FDA 510(k) record lists Exactech, Inc. as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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