FDA 510(k)

解剖肩部系統

K 號：K193099 · 2020-01-29

決定日期2020-01-29

產品代碼PHX

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決定相當於

器材摘要

Anatomical Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2020-01-29 under 510(k) number K193099. 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 Anatomical Shoulder System?

Anatomical Shoulder System is a medical device that received FDA 510(k) clearance on 2020-01-29. The listed applicant is Zimmer GmbH. The 510(k) number is K193099.

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

Anatomical Shoulder System received FDA 510(k) clearance on 2020-01-29, under 510(k) number K193099.

Who is the listed applicant for Anatomical Shoulder System?

The FDA 510(k) record lists Zimmer GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anatomical Shoulder System?

The FDA product code for Anatomical Shoulder System is PHX.

其他以 Zimmer GmbH 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。

K211047CoCr 頭部 K200814Affixus(R) 自然釘(R) 系統上臂釘 K200112齊默髋關節置換設備 K193050Alloclassic Zweymuller SL股骨柄，Alloclassic Zweymuller SL偏心股骨柄 K193030Avenir Muller 植入物，Avenir 粘合固定髋關節植入物 K192236Fitmore 髋關節植入體

查看所有 19 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

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