FDA 510(k)

Aequalis PerFORM 反轉盂蓋，Aequalis PerFORM + 反轉盂蓋

K 號：K183696 · 2019-01-30

決定日期2019-01-30

產品代碼PHX

諮詢委員會或

決定相當於

器材摘要

Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid is the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2019-01-30 under 510(k) number K183696. 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 Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid?

Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid is a medical device that received FDA 510(k) clearance on 2019-01-30. The listed applicant is Tornier, Inc.. The 510(k) number is K183696.

When did Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid receive FDA 510(k) clearance?

Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid received FDA 510(k) clearance on 2019-01-30, under 510(k) number K183696.

Who is the listed applicant for Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid?

FDA 510(k) 記錄將 Tornier, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid?

The FDA product code for Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid is PHX.

其他以 Tornier, 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。

K260721Tornier Perform 高級肩胛盂 K252788Tornier Perform™ 反向單柱盂蓋 (Perform Mono)K251686Tornier 臂骨重建系統 Max (Tornier HRS Max)K230352Tornier肩胛骨釘與Tornier長肩胛骨釘 K220914Tornier Perform 臂骨系統 – 骨折 K220418Tornier Perform 臂骨系統 – 齒冠式

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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

官方來源

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