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FDA 510(k)

Airlock® Ankle Plating System

K-Number: K260274 · 2026-03-25

ApplicantNovastep SAS
Decision Date2026-03-25
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Airlock® Ankle Plating System is a medical device manufactured by Novastep SAS. It received FDA 510(k) clearance on 2026-03-25 under approval number K260274. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Airlock® Ankle Plating System?

Airlock® Ankle Plating System is a medical device that received FDA 510(k) clearance on 2026-03-25. It is manufactured by Novastep SAS. The 510(k) number is K260274.

When was Airlock® Ankle Plating System approved by the FDA?

Airlock® Ankle Plating System received FDA 510(k) clearance on 2026-03-25, under approval number K260274.

What company makes Airlock® Ankle Plating System?

Airlock® Ankle Plating System is manufactured by Novastep SAS.

What is the FDA product code for Airlock® Ankle Plating System?

The FDA product code for Airlock® Ankle Plating System is HRS.

Related Clinical Trials

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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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