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FDA 510(k)

Austin Miller 大型外固定系統

K 號:K181528 · 2019-02-28

決定日期2019-02-28
產品代碼KTT
諮詢委員會或
決定相當於

器材摘要

Austin Miller Large External Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Austin Miller Trauma, LLC. It received FDA 510(k) clearance on 2019-02-28 under 510(k) number K181528. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Austin Miller Large External Fixation System?

Austin Miller Large External Fixation System is a medical device that received FDA 510(k) clearance on 2019-02-28. The listed applicant is Austin Miller Trauma, LLC. The 510(k) number is K181528.

When did Austin Miller Large External Fixation System receive FDA 510(k) clearance?

Austin Miller Large External Fixation System received FDA 510(k) clearance on 2019-02-28, under 510(k) number K181528.

Who is the listed applicant for Austin Miller Large External Fixation System?

The FDA 510(k) record lists Austin Miller Trauma, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Austin Miller Large External Fixation System?

The FDA product code for Austin Miller Large External Fixation System is KTT.

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相關器械(代碼:KTT)

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。

官方來源

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