FDA 510(k)

ExactechGPS 全肩關節應用

K 號：K173372 · 2017-11-24

決定日期2017-11-24

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 Shoulder 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 2017-11-24 under 510(k) number K173372. 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 Shoulder Application?

ExactechGPS Total Shoulder Application is a medical device that received FDA 510(k) clearance on 2017-11-24. The listed applicant is Blue Ortho. The 510(k) number is K173372.

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

ExactechGPS Total Shoulder Application received FDA 510(k) clearance on 2017-11-24, under 510(k) number K173372.

Who is the listed applicant for ExactechGPS Total Shoulder 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 Shoulder Application?

The FDA product code for ExactechGPS Total Shoulder 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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