FDA 510(k)

Auxein 钉固定系統

K 號：K192003 · 2020-06-10

決定日期2020-06-10

產品代碼JDS

諮詢委員會或

決定相當於

器材摘要

Auxein Nailing System is the device name listed in this FDA 510(k) record. The listed applicant is Auxein Medical Private Limited. It received FDA 510(k) clearance on 2020-06-10 under 510(k) number K192003. The device is classified under product code JDS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Auxein Nailing System?

Auxein Nailing System is a medical device that received FDA 510(k) clearance on 2020-06-10. The listed applicant is Auxein Medical Private Limited. The 510(k) number is K192003.

When did Auxein Nailing System receive FDA 510(k) clearance?

Auxein Nailing System received FDA 510(k) clearance on 2020-06-10, under 510(k) number K192003.

Who is the listed applicant for Auxein Nailing System?

The FDA 510(k) record lists Auxein Medical Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Auxein Nailing System?

The FDA product code for Auxein Nailing System is JDS.

其他以 Auxein Medical Private Limited 為申請人之記錄

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相關器械（代碼：JDS）

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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