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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 the device name listed in this FDA 510(k) record. The listed applicant is Novastep SAS. It received FDA 510(k) clearance on 2026-03-25 under 510(k) 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. The listed applicant is Novastep SAS. The 510(k) number is K260274.

When did Airlock® Ankle Plating System receive FDA 510(k) clearance?

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

Who is the listed applicant for Airlock® Ankle Plating System?

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

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

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

Related Devices (Code: HRS)

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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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.

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