FDA 510(k)

TiN塗層的肱骨頭

K 號：K191698 · 2020-07-16

決定日期2020-07-16

產品代碼KWT

諮詢委員會或

決定相當於

器材摘要

TiN Coated Humeral Head 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 2020-07-16 under 510(k) number K191698. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TiN Coated Humeral Head?

TiN Coated Humeral Head is a medical device that received FDA 510(k) clearance on 2020-07-16. The listed applicant is Fx Shoulder USA, Inc.. The 510(k) number is K191698.

When did TiN Coated Humeral Head receive FDA 510(k) clearance?

TiN Coated Humeral Head received FDA 510(k) clearance on 2020-07-16, under 510(k) number K191698.

Who is the listed applicant for TiN Coated Humeral Head?

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 TiN Coated Humeral Head?

The FDA product code for TiN Coated Humeral Head is KWT.

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 K201391Easytech® 骨解剖肩部系統

查看所有 11 項裝置 →

相關器械（代碼：KWT）

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。

K262173N22 選擇性肱骨頭Shoulder Innovations, Inc.K250713Equinoxe® 肱骨重建義肢；Equinoxe® 無柄肩關節植入體Exactech, Inc.K251686Tornier 臂骨重建系統 Max (Tornier HRS Max)Tornier, Inc.K241944AGILON® XO肩部置換系統Implantcast GmbH K241817InSet 全肩關節系統Shoulder Innovations, Inc.K231657AGILON® XO肩部置換系統Implantcast GmbH

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。