FDA 510(k)

CUVIS-關節（CJ150）

K 號：K252037 · 2026-03-25

決定日期2026-03-25

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-joint (CJ150) is the device name listed in this FDA 510(k) record. The listed applicant is Curexo, Inc.. It received FDA 510(k) clearance on 2026-03-25 under 510(k) number K252037. 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-joint (CJ150)?

CUVIS-joint (CJ150) is a medical device that received FDA 510(k) clearance on 2026-03-25. The listed applicant is Curexo, Inc.. The 510(k) number is K252037.

When did CUVIS-joint (CJ150) receive FDA 510(k) clearance?

CUVIS-joint (CJ150) received FDA 510(k) clearance on 2026-03-25, under 510(k) number K252037.

Who is the listed applicant for CUVIS-joint (CJ150)?

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-joint (CJ150)?

The FDA product code for CUVIS-joint (CJ150) 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）

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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