FDA 510(k)

胡美克TiN塗層球顥

K 號：K191146 · 2020-07-15

決定日期2020-07-15

產品代碼PHX

諮詢委員會或

決定相當於

器材摘要

Humelock TiN Coated Glenosphere 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 2020-07-15 under 510(k) number K191146. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Humelock TiN Coated Glenosphere?

Humelock TiN Coated Glenosphere is a medical device that received FDA 510(k) clearance on 2020-07-15. The listed applicant is Fx Shoulder USA, Inc.. The 510(k) number is K191146.

When did Humelock TiN Coated Glenosphere receive FDA 510(k) clearance?

Humelock TiN Coated Glenosphere received FDA 510(k) clearance on 2020-07-15, under 510(k) number K191146.

Who is the listed applicant for Humelock TiN Coated Glenosphere?

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 Humelock TiN Coated Glenosphere?

The FDA product code for Humelock TiN Coated Glenosphere is PHX.

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：PHX）

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。

K260556Veritas肩部系統Restor3D K261683Augment 偏心儀器系統Zimmer, Inc.K260102Tornier Perform Reversed Glenoid和Tornier Perform Reversed Augmented Glenoid Shoulder System的設備名稱Stryker Corporation (Tornier, Inc.)K261016MSS - 肱骨反覆蓋擴充件Medacta International, SA K253992Veritas逆向全肩關節系統Restor3D K252404全面反向肩蓋 - HA 髖關節基板Biomet Orthopedics

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。