FDA 510(k)

Arsenal Ankle Plating System

K 號：K212378 · 2022-02-23

決定日期2022-02-23

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

Arsenal Ankle Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Trilliant Surgical. It received FDA 510(k) clearance on 2022-02-23 under 510(k) number K212378. 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 Arsenal Ankle Plating System?

Arsenal Ankle Plating System is a medical device that received FDA 510(k) clearance on 2022-02-23. The listed applicant is Trilliant Surgical. The 510(k) number is K212378.

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

Arsenal Ankle Plating System received FDA 510(k) clearance on 2022-02-23, under 510(k) number K212378.

Who is the listed applicant for Arsenal Ankle Plating System?

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

What is the FDA product code for Arsenal Ankle Plating System?

The FDA product code for Arsenal Ankle Plating System is HRS.

其他以 Trilliant Surgical 為申請人之記錄

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。

K191009Arsenal Plating System K181898雙階段植入系統 K172405SNIPER 鋼釘系統，非無菌

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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