FDA 510(k)

ヤフア脊椎システム

K番号: K152324 · 2016-02-01

申請者Beijing Weigao Yahua Artificial Joint Development Co. , Ltd.

決定日2016-02-01

製品コードMNI

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

YAHUA Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Weigao Yahua Artificial Joint Development Co. , Ltd.. It received FDA 510(k) clearance on 2016-02-01 under 510(k) number K152324. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the YAHUA Spinal System?

YAHUA Spinal System is a medical device that received FDA 510(k) clearance on 2016-02-01. The listed applicant is Beijing Weigao Yahua Artificial Joint Development Co. , Ltd.. The 510(k) number is K152324.

When did YAHUA Spinal System receive FDA 510(k) clearance?

YAHUA Spinal System received FDA 510(k) clearance on 2016-02-01, under 510(k) number K152324.

Who is the listed applicant for YAHUA Spinal System?

The FDA 510(k) record lists Beijing Weigao Yahua Artificial Joint Development Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for YAHUA Spinal System?

The FDA product code for YAHUA Spinal System is MNI.

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ヤフア脊椎システム

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：MNI）

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