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FDA 510(k)

ApolloKnee

K 號:K231172 · 2023-07-26

決定日期2023-07-26
產品代碼OLO
諮詢委員會NE (請提供完整的英文描述,以便進行翻譯。)
決定相當於

器材摘要

ApolloKnee is the device name listed in this FDA 510(k) record. The listed applicant is Corin U.S.A. Limited. It received FDA 510(k) clearance on 2023-07-26 under 510(k) number K231172. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ApolloKnee?

ApolloKnee is a medical device that received FDA 510(k) clearance on 2023-07-26. The listed applicant is Corin U.S.A. Limited. The 510(k) number is K231172.

When did ApolloKnee receive FDA 510(k) clearance?

ApolloKnee received FDA 510(k) clearance on 2023-07-26, under 510(k) number K231172.

Who is the listed applicant for ApolloKnee?

The FDA 510(k) record lists Corin U.S.A. Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ApolloKnee?

The FDA product code for ApolloKnee is OLO.

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其他以 Corin U.S.A. Limited 為申請人之記錄

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相關器械(代碼:OLO)

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官方來源

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