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FDA 510(k)

Hintermann Series H2 Total Ankle System

K-Number: K240475 · 2024-12-02

ApplicantVilex, LLC
Decision Date2024-12-02
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Hintermann Series H2 Total Ankle System is a medical device manufactured by Vilex, LLC. It received FDA 510(k) clearance on 2024-12-02 under approval number K240475. 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 Hintermann Series H2 Total Ankle System?

Hintermann Series H2 Total Ankle System is a medical device that received FDA 510(k) clearance on 2024-12-02. It is manufactured by Vilex, LLC. The 510(k) number is K240475.

When was Hintermann Series H2 Total Ankle System approved by the FDA?

Hintermann Series H2 Total Ankle System received FDA 510(k) clearance on 2024-12-02, under approval number K240475.

What company makes Hintermann Series H2 Total Ankle System?

Hintermann Series H2 Total Ankle System is manufactured by Vilex, LLC.

What is the FDA product code for Hintermann Series H2 Total Ankle System?

The FDA product code for Hintermann Series H2 Total Ankle System is HSN.

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Related PubMed Literature

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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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