FDA 510(k)

微創醫療骨科全髋關節系統 MR 標籤

K 號：K173898 · 2018-09-20

決定日期2018-09-20

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

MicroPort Orthopedics Total Hip Systems MR Labeling is the device name listed in this FDA 510(k) record. The listed applicant is Microport Orthopedics Inc. (Mpo). It received FDA 510(k) clearance on 2018-09-20 under 510(k) number K173898. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MicroPort Orthopedics Total Hip Systems MR Labeling?

MicroPort Orthopedics Total Hip Systems MR Labeling is a medical device that received FDA 510(k) clearance on 2018-09-20. The listed applicant is Microport Orthopedics Inc. (Mpo). The 510(k) number is K173898.

When did MicroPort Orthopedics Total Hip Systems MR Labeling receive FDA 510(k) clearance?

MicroPort Orthopedics Total Hip Systems MR Labeling received FDA 510(k) clearance on 2018-09-20, under 510(k) number K173898.

Who is the listed applicant for MicroPort Orthopedics Total Hip Systems MR Labeling?

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

What is the FDA product code for MicroPort Orthopedics Total Hip Systems MR Labeling?

The FDA product code for MicroPort Orthopedics Total Hip Systems MR Labeling is LZO.

相關器械（代碼：LZO）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：LZO）

官方來源