FDA 510(k)

32mm 開放式股骨頭和肱骨杯

K 號：K192206 · 2019-10-08

決定日期2019-10-08

產品代碼PHX

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決定相當於

器材摘要

32mm Glenosphere and Humeral Cup 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 2019-10-08 under 510(k) number K192206. 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 32mm Glenosphere and Humeral Cup?

32mm Glenosphere and Humeral Cup is a medical device that received FDA 510(k) clearance on 2019-10-08. The listed applicant is Fx Shoulder USA, Inc.. The 510(k) number is K192206.

When did 32mm Glenosphere and Humeral Cup receive FDA 510(k) clearance?

32mm Glenosphere and Humeral Cup received FDA 510(k) clearance on 2019-10-08, under 510(k) number K192206.

Who is the listed applicant for 32mm Glenosphere and Humeral Cup?

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 32mm Glenosphere and Humeral Cup?

The FDA product code for 32mm Glenosphere and Humeral Cup is PHX.

其他以 Fx Shoulder USA, Inc. 為申請人之記錄

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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

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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

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