FDA 510(k)

ExactechGPS® 全踝應用程序

K 號：K232521 · 2023-11-16

決定日期2023-11-16

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

ExactechGPS® Total Ankle Application is the device name listed in this FDA 510(k) record. The listed applicant is Blue Ortho. It received FDA 510(k) clearance on 2023-11-16 under 510(k) number K232521. 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 ExactechGPS® Total Ankle Application?

ExactechGPS® Total Ankle Application is a medical device that received FDA 510(k) clearance on 2023-11-16. The listed applicant is Blue Ortho. The 510(k) number is K232521.

When did ExactechGPS® Total Ankle Application receive FDA 510(k) clearance?

ExactechGPS® Total Ankle Application received FDA 510(k) clearance on 2023-11-16, under 510(k) number K232521.

Who is the listed applicant for ExactechGPS® Total Ankle Application?

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

What is the FDA product code for ExactechGPS® Total Ankle Application?

The FDA product code for ExactechGPS® Total Ankle Application is OLO.

其他以 Blue Ortho 為申請人之記錄

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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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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官方來源

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