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FDA 510(k)

Cadence Total Ankle System

K-Number: K201507 · 2020-06-29

Decision Date2020-06-29
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cadence Total Ankle System is a medical device manufactured by Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2020-06-29 under approval number K201507. 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 Cadence Total Ankle System?

Cadence Total Ankle System is a medical device that received FDA 510(k) clearance on 2020-06-29. It is manufactured by Integra LifeSciences Corporation. The 510(k) number is K201507.

When was Cadence Total Ankle System approved by the FDA?

Cadence Total Ankle System received FDA 510(k) clearance on 2020-06-29, under approval number K201507.

What company makes Cadence Total Ankle System?

Cadence Total Ankle System is manufactured by Integra LifeSciences Corporation.

What is the FDA product code for Cadence Total Ankle System?

The FDA product code for Cadence Total Ankle System is HSN.

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Official Source

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