FDA 510(k)

CUVIS脊椎

K 號：K223558 · 2023-06-22

決定日期2023-06-22

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

CUVIS-spine is the device name listed in this FDA 510(k) record. The listed applicant is Curexo, Inc.. It received FDA 510(k) clearance on 2023-06-22 under 510(k) number K223558. 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 CUVIS-spine?

CUVIS-spine is a medical device that received FDA 510(k) clearance on 2023-06-22. The listed applicant is Curexo, Inc.. The 510(k) number is K223558.

When did CUVIS-spine receive FDA 510(k) clearance?

CUVIS-spine received FDA 510(k) clearance on 2023-06-22, under 510(k) number K223558.

Who is the listed applicant for CUVIS-spine?

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

What is the FDA product code for CUVIS-spine?

The FDA product code for CUVIS-spine is OLO.

其他以 Curexo, Inc. 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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