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FDA 510(k)

AutoStrut G2

K 號:K202810 · 2021-01-06

決定日期2021-01-06
產品代碼KTT
諮詢委員會或
決定相當於

器材摘要

AutoStrut G2 is the device name listed in this FDA 510(k) record. The listed applicant is Orthospin, Ltd.. It received FDA 510(k) clearance on 2021-01-06 under 510(k) number K202810. 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 AutoStrut G2?

AutoStrut G2 is a medical device that received FDA 510(k) clearance on 2021-01-06. The listed applicant is Orthospin, Ltd.. The 510(k) number is K202810.

When did AutoStrut G2 receive FDA 510(k) clearance?

AutoStrut G2 received FDA 510(k) clearance on 2021-01-06, under 510(k) number K202810.

Who is the listed applicant for AutoStrut G2?

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

What is the FDA product code for AutoStrut G2?

The FDA product code for AutoStrut G2 is KTT.

相關臨床試驗

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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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