FDA 510(k)

Tornier Perform 臂骨系統 – 齒冠式

K 號：K220418 · 2022-09-14

決定日期2022-09-14

產品代碼PKC

諮詢委員會或

決定相當於

器材摘要

Tornier Perform Humeral System – Stemless is the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2022-09-14 under 510(k) number K220418. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tornier Perform Humeral System – Stemless?

Tornier Perform Humeral System – Stemless is a medical device that received FDA 510(k) clearance on 2022-09-14. The listed applicant is Tornier, Inc.. The 510(k) number is K220418.

When did Tornier Perform Humeral System – Stemless receive FDA 510(k) clearance?

Tornier Perform Humeral System – Stemless received FDA 510(k) clearance on 2022-09-14, under 510(k) number K220418.

Who is the listed applicant for Tornier Perform Humeral System – Stemless?

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 Tornier Perform Humeral System – Stemless?

The FDA product code for Tornier Perform Humeral System – Stemless is PKC.

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 K211359Tornier Perform™ 為患者量身打造的逆向肩胛盂及 BLUEPRINT™ 患者專屬儀器

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相關器械（代碼：PKC）

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。

K262955OsseoFit無柄肩部系統Zimmer, Inc.K254154FX V135 EASYTECH® 肩關節系統FX Shoulder Solutions, Inc.K252129AETOS肩關節系統無柄肱骨假體Smith & Nephew, Inc.K243248INHANCE INTACT™Depuy Ireland UC K241873OsseoFit無柄肩部系統Zimmer, Inc.K240716AETOS肩關節系統無柄肱骨假體Smith & Nephew, Inc.

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。