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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 the device name listed in this FDA 510(k) record. The listed applicant is Vilex, LLC. It received FDA 510(k) clearance on 2024-12-02 under 510(k) 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. The listed applicant is Vilex, LLC. The 510(k) number is K240475.

When did Hintermann Series H2 Total Ankle System receive FDA 510(k) clearance?

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

Who is the listed applicant for Hintermann Series H2 Total Ankle System?

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

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.

Related Clinical Trials

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.

NCT04770870Post Approval Study2: Hintermann Series H3 Total Ankle Replacement SystemACTIVE_NOT_RECRUITING

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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.

K253159Prophecy Incompass Surgical Planning SystemWright Medical Technology, Inc. (Stryker)K252454Kinos Total Ankle SystemRestor3DK250037Incompass Total Ankle SystemWright Medical Technology, Inc. (Stryker)K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc.K241999Prophecy Surgical Planning SystemWright Medical Technology, Inc. (Stryker)K242868Kinos Total Ankle SystemRestor3D

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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