FDA 510(k)

ロッキングプレートシステム

K番号: K162380 · 2017-05-02

申請者Beijing Keyi Medical Device Technology Co., Ltd.

決定日2017-05-02

製品コードHRS

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

Locking Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Keyi Medical Device Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-05-02 under 510(k) number K162380. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Locking Plate System?

Locking Plate System is a medical device that received FDA 510(k) clearance on 2017-05-02. The listed applicant is Beijing Keyi Medical Device Technology Co., Ltd.. The 510(k) number is K162380.

When did Locking Plate System receive FDA 510(k) clearance?

Locking Plate System received FDA 510(k) clearance on 2017-05-02, under 510(k) number K162380.

Who is the listed applicant for Locking Plate System?

The FDA 510(k) record lists Beijing Keyi Medical Device Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Locking Plate System?

The FDA product code for Locking Plate System is HRS.

申請者としてBeijing Keyi Medical Device Technology Co., Ltd.を記載するその他の記録

K230120Keyi 全膝システム K191826Keyi 全髋関節システム K190567Keyi脊椎固定システム

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