FDA 510(k)

Restor3d ユーティリティ・ウェッジ

K番号: K201314 · 2021-06-17

決定日2021-06-17

製品コードPLF

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

Restor3d Utility Wedge is the device name listed in this FDA 510(k) record. The listed applicant is Restor3D, Inc.. It received FDA 510(k) clearance on 2021-06-17 under 510(k) number K201314. The device is classified under product code PLF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Restor3d Utility Wedge?

Restor3d Utility Wedge is a medical device that received FDA 510(k) clearance on 2021-06-17. The listed applicant is Restor3D, Inc.. The 510(k) number is K201314.

When did Restor3d Utility Wedge receive FDA 510(k) clearance?

Restor3d Utility Wedge received FDA 510(k) clearance on 2021-06-17, under 510(k) number K201314.

Who is the listed applicant for Restor3d Utility Wedge?

The FDA 510(k) record lists Restor3D, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Restor3d Utility Wedge?

The FDA product code for Restor3d Utility Wedge is PLF.

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公式ソース

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