FDA 510(k)

Easytech® 骨解剖肩部系統

K 號：K201391 · 2021-02-16

決定日期2021-02-16

產品代碼PKC

諮詢委員會或

決定相當於

器材摘要

Easytech® Anatomical Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Fx Shoulder USA, Inc.. It received FDA 510(k) clearance on 2021-02-16 under 510(k) number K201391. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Easytech® Anatomical Shoulder System?

Easytech® Anatomical Shoulder System is a medical device that received FDA 510(k) clearance on 2021-02-16. The listed applicant is Fx Shoulder USA, Inc.. The 510(k) number is K201391.

When did Easytech® Anatomical Shoulder System receive FDA 510(k) clearance?

Easytech® Anatomical Shoulder System received FDA 510(k) clearance on 2021-02-16, under 510(k) number K201391.

Who is the listed applicant for Easytech® Anatomical Shoulder System?

The FDA 510(k) record lists Fx Shoulder USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Easytech® Anatomical Shoulder System?

The FDA product code for Easytech® Anatomical Shoulder System is PKC.

其他以 Fx Shoulder USA, Inc. 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。

K240278全邊緣側向及增強基板 K223801FX V135™ 肩關節假肢 K222936Humeris® 135 肩部系統 K213117FX V135 肩部義肢 K210790側向增強底板 K191698TiN塗層的肱骨頭

查看所有 11 項裝置 →

相關器械（代碼：PKC）

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。

K262955OsseoFit無柄肩部系統Zimmer, Inc.K254154FX V135 EASYTECH® 肩關節系統FX Shoulder Solutions, Inc.K252129AETOS肩關節系統無柄肱骨假體Smith & Nephew, Inc.K243248INHANCE INTACT™Depuy Ireland UC K241873OsseoFit無柄肩部系統Zimmer, Inc.K240716AETOS肩關節系統無柄肱骨假體Smith & Nephew, Inc.

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。