FDA 510(k)

Align 前腳踝融合板

K 號：K160191 · 2016-03-25

決定日期2016-03-25

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

Align Anterior Ankle Fusion Plate is the device name listed in this FDA 510(k) record. The listed applicant is Extremity Medical, LLC. It received FDA 510(k) clearance on 2016-03-25 under 510(k) number K160191. 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 Align Anterior Ankle Fusion Plate?

Align Anterior Ankle Fusion Plate is a medical device that received FDA 510(k) clearance on 2016-03-25. The listed applicant is Extremity Medical, LLC. The 510(k) number is K160191.

When did Align Anterior Ankle Fusion Plate receive FDA 510(k) clearance?

Align Anterior Ankle Fusion Plate received FDA 510(k) clearance on 2016-03-25, under 510(k) number K160191.

Who is the listed applicant for Align Anterior Ankle Fusion Plate?

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

What is the FDA product code for Align Anterior Ankle Fusion Plate?

The FDA product code for Align Anterior Ankle Fusion Plate is HRS.

其他以 Extremity Medical, LLC 為申請人之記錄

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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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