FDA 510(k)

MPO全膝系統 MR標籤

K 號：K152631 · 2016-03-23

決定日期2016-03-23

產品代碼HRY

諮詢委員會或

決定相當於

器材摘要

MPO Total Knee Systems MR Labeling is the device name listed in this FDA 510(k) record. The listed applicant is Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2016-03-23 under 510(k) number K152631. The device is classified under product code HRY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MPO Total Knee Systems MR Labeling?

MPO Total Knee Systems MR Labeling is a medical device that received FDA 510(k) clearance on 2016-03-23. The listed applicant is Microport Orthopedics, Inc.. The 510(k) number is K152631.

When did MPO Total Knee Systems MR Labeling receive FDA 510(k) clearance?

MPO Total Knee Systems MR Labeling received FDA 510(k) clearance on 2016-03-23, under 510(k) number K152631.

Who is the listed applicant for MPO Total Knee Systems MR Labeling?

FDA 510(k) 記錄將 Microport Orthopedics, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for MPO Total Knee Systems MR Labeling?

The FDA product code for MPO Total Knee Systems MR Labeling is HRY.

其他以 Microport Orthopedics, Inc. 為申請人之記錄

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相關器械（代碼：HRY）

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。

K193549SIGMA 高性能（HP）部分膝關節系統Depuy Ireland UC K190633NanoOrtho NanoKnee® 系統Nanoortho, LLC

官方來源

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