FDA 510(k)

パルカスSLiKフィックスボルト

K番号: K170877 · 2017-06-02

決定日2017-06-02

製品コードMBI

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

Parcus SLiK Fix Screw is the device name listed in this FDA 510(k) record. The listed applicant is Parcus Medical. It received FDA 510(k) clearance on 2017-06-02 under 510(k) number K170877. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Parcus SLiK Fix Screw?

Parcus SLiK Fix Screw is a medical device that received FDA 510(k) clearance on 2017-06-02. The listed applicant is Parcus Medical. The 510(k) number is K170877.

When did Parcus SLiK Fix Screw receive FDA 510(k) clearance?

Parcus SLiK Fix Screw received FDA 510(k) clearance on 2017-06-02, under 510(k) number K170877.

Who is the listed applicant for Parcus SLiK Fix Screw?

The FDA 510(k) record lists Parcus Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Parcus SLiK Fix Screw?

The FDA product code for Parcus SLiK Fix Screw is MBI.

申請者としてParcus Medicalを記載するその他の記録

K232513X-Twistバイオコンポジット縫合アンカー K170327パルカスSLiKアンカース

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