FDA 510(k)

Arzzt 腕骨遠端及尺骨系統

K 號：K182650 · 2019-06-10

決定日期2019-06-10

產品代碼HRS

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決定相當於

器材摘要

Arzzt Distal Radius and Ulna System is the device name listed in this FDA 510(k) record. The listed applicant is Truemed Group, LLC. It received FDA 510(k) clearance on 2019-06-10 under 510(k) number K182650. 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 Arzzt Distal Radius and Ulna System?

Arzzt Distal Radius and Ulna System is a medical device that received FDA 510(k) clearance on 2019-06-10. The listed applicant is Truemed Group, LLC. The 510(k) number is K182650.

When did Arzzt Distal Radius and Ulna System receive FDA 510(k) clearance?

Arzzt Distal Radius and Ulna System received FDA 510(k) clearance on 2019-06-10, under 510(k) number K182650.

Who is the listed applicant for Arzzt Distal Radius and Ulna System?

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

What is the FDA product code for Arzzt Distal Radius and Ulna System?

The FDA product code for Arzzt Distal Radius and Ulna System is HRS.

其他以 Truemed Group, LLC 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。

K200575TRUEMED 手、足及踝板系統 K172189In Hilden 肱骨針針頭醫療設備，In Hilden 穿刺胫骨針針頭醫療設備，In Hilden 髋骨針針頭醫療設備 & In Hilden 逆行針針頭醫療設備 K162507Arzzt 3.5 / 4.5 小型及大型碎片系統

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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