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FDA 510(k)

上臂杯穩定性 & 上臂杯135/145°穩定性

K 號：K193394 · 2020-04-29

申請人Fx Shoulder USA, Inc.
決定日期2020-04-29
產品代碼PHX
諮詢委員會或
決定相當於

器材摘要

Humeral Cup Stability & Humeral Cup 135/145o Stability 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 2020-04-29 under 510(k) number K193394. 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 Humeral Cup Stability & Humeral Cup 135/145o Stability?

Humeral Cup Stability & Humeral Cup 135/145o Stability is a medical device that received FDA 510(k) clearance on 2020-04-29. The listed applicant is Fx Shoulder USA, Inc.. The 510(k) number is K193394.

When did Humeral Cup Stability & Humeral Cup 135/145o Stability receive FDA 510(k) clearance?

Humeral Cup Stability & Humeral Cup 135/145o Stability received FDA 510(k) clearance on 2020-04-29, under 510(k) number K193394.

Who is the listed applicant for Humeral Cup Stability & Humeral Cup 135/145o Stability?

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 Humeral Cup Stability & Humeral Cup 135/145o Stability?

The FDA product code for Humeral Cup Stability & Humeral Cup 135/145o Stability is PHX.

相關臨床試驗

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。

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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。

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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Restor3DK261683Augment 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, SAK253992Veritas逆向全肩關節系統Restor3DK252404全面反向肩蓋 - HA 髖關節基板Biomet Orthopedics

官方來源

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