FDA 510(k)

遠端桡骨板固定系統

K 號：K162635 · 2016-10-21

決定日期2016-10-21

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

Distal Radius Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Miami Device Solutions, LLC. It received FDA 510(k) clearance on 2016-10-21 under 510(k) number K162635. 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 Distal Radius Plating System?

Distal Radius Plating System is a medical device that received FDA 510(k) clearance on 2016-10-21. The listed applicant is Miami Device Solutions, LLC. The 510(k) number is K162635.

When did Distal Radius Plating System receive FDA 510(k) clearance?

Distal Radius Plating System received FDA 510(k) clearance on 2016-10-21, under 510(k) number K162635.

Who is the listed applicant for Distal Radius Plating System?

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

What is the FDA product code for Distal Radius Plating System?

The FDA product code for Distal Radius Plating System is HRS.

其他以 Miami Device Solutions, 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。

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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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