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FDA 510(k)

LOSPA TKR系統儀器設備，EXULT TKR系統儀器設備

K 號：K222278 · 2022-08-26

申請人Corentec Co., Ltd.
決定日期2022-08-26
產品代碼JWH
諮詢委員會或
決定相當於

器材摘要

LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation is the device name listed in this FDA 510(k) record. The listed applicant is Corentec Co., Ltd.. It received FDA 510(k) clearance on 2022-08-26 under 510(k) number K222278. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation?

LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation is a medical device that received FDA 510(k) clearance on 2022-08-26. The listed applicant is Corentec Co., Ltd.. The 510(k) number is K222278.

When did LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation receive FDA 510(k) clearance?

LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation received FDA 510(k) clearance on 2022-08-26, under 510(k) number K222278.

Who is the listed applicant for LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation?

The FDA 510(k) record lists Corentec Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation?

The FDA product code for LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation is JWH.

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 Corentec Co., Ltd. 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：JWH）

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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官方來源

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