FDA 510(k)

Acculoc Total Knee System

K番号: K170753 · 2018-03-23

決定日2018-03-23

製品コードJWH

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

Acculoc Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Rootloc Co., Ltd.. It received FDA 510(k) clearance on 2018-03-23 under 510(k) number K170753. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Acculoc Total Knee System?

Acculoc Total Knee System is a medical device that received FDA 510(k) clearance on 2018-03-23. The listed applicant is Rootloc Co., Ltd.. The 510(k) number is K170753.

When did Acculoc Total Knee System receive FDA 510(k) clearance?

Acculoc Total Knee System received FDA 510(k) clearance on 2018-03-23, under 510(k) number K170753.

Who is the listed applicant for Acculoc Total Knee System?

The FDA 510(k) record lists Rootloc Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Acculoc Total Knee System?

The FDA product code for Acculoc Total Knee System is JWH.

申請者としてRootloc Co., Ltd.を記載するその他の記録

K182370Acculoc Total Knee System

公式ソース

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