Airlock® 腳踝板系統
K 號：K260274 · 2026-03-25
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器材摘要
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.
常見問題
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.
相關臨床試驗
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相關器械（代碼：HRS）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
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官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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