FDA 510(k)

TEMA 肘關節系統 - 線路擴充

K 號：K222807 · 2022-10-26

決定日期2022-10-26

產品代碼JDB

諮詢委員會或

決定相當於

器材摘要

TEMA Elbow system - Line extension is the device name listed in this FDA 510(k) record. The listed applicant is Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2022-10-26 under 510(k) number K222807. The device is classified under product code JDB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TEMA Elbow system - Line extension?

TEMA Elbow system - Line extension is a medical device that received FDA 510(k) clearance on 2022-10-26. The listed applicant is Lima Corporate S.P.A.. The 510(k) number is K222807.

When did TEMA Elbow system - Line extension receive FDA 510(k) clearance?

TEMA Elbow system - Line extension received FDA 510(k) clearance on 2022-10-26, under 510(k) number K222807.

Who is the listed applicant for TEMA Elbow system - Line extension?

The FDA 510(k) record lists Lima Corporate S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEMA Elbow system - Line extension?

The FDA product code for TEMA Elbow system - Line extension is JDB.

其他以 Lima Corporate S.P.A. 為申請人之記錄

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相關器械（代碼：JDB）

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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