FDA 510(k)

金属カナリ化ボルト

K番号: K221090 · 2023-01-10

決定日2023-01-10

製品コードHWC

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

Metal Cannulated Screw is the device name listed in this FDA 510(k) record. The listed applicant is Double Medical Technology, Inc.. It received FDA 510(k) clearance on 2023-01-10 under 510(k) number K221090. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

よくある質問

What is the Metal Cannulated Screw?

Metal Cannulated Screw is a medical device that received FDA 510(k) clearance on 2023-01-10. The listed applicant is Double Medical Technology, Inc.. The 510(k) number is K221090.

When did Metal Cannulated Screw receive FDA 510(k) clearance?

Metal Cannulated Screw received FDA 510(k) clearance on 2023-01-10, under 510(k) number K221090.

Who is the listed applicant for Metal Cannulated Screw?

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

What is the FDA product code for Metal Cannulated Screw?

The FDA product code for Metal Cannulated Screw is HWC. This falls under the Cardiovascular category.

申請者としてDouble Medical Technology, Inc.を記載するその他の記録

K252729ユニバーサル脊椎システム K242348ロッキング・スクリュー、CoCrMo K233078後頸椎脊柱システム K223753頸椎板システム K221150高度な骨プレート K221088解剖学的骨プレート

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