FDA 510(k)

PERFORM 肱骨系統 – 植入體

K 號：K201315 · 2020-09-11

決定日期2020-09-11

產品代碼PAO

諮詢委員會或

決定相當於

器材摘要

PERFORM Humeral System – Stem is the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2020-09-11 under 510(k) number K201315. The device is classified under product code PAO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PERFORM Humeral System – Stem?

PERFORM Humeral System – Stem is a medical device that received FDA 510(k) clearance on 2020-09-11. The listed applicant is Tornier, Inc.. The 510(k) number is K201315.

When did PERFORM Humeral System – Stem receive FDA 510(k) clearance?

PERFORM Humeral System – Stem received FDA 510(k) clearance on 2020-09-11, under 510(k) number K201315.

Who is the listed applicant for PERFORM Humeral System – Stem?

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 PERFORM Humeral System – Stem?

The FDA product code for PERFORM Humeral System – Stem is PAO.

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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官方來源

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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。

器材摘要

常見問題

相關臨床試驗

其他以 Tornier, Inc. 為申請人之記錄

官方來源