FDA 510(k)

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K番号: K143596 · 2016-02-05

決定日2016-02-05

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

MINIARS SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Overmed Srl.. It received FDA 510(k) clearance on 2016-02-05 under 510(k) number K143596. 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 MINIARS SCREWS?

MINIARS SCREWS is a medical device that received FDA 510(k) clearance on 2016-02-05. The listed applicant is Overmed Srl.. The 510(k) number is K143596.

When did MINIARS SCREWS receive FDA 510(k) clearance?

MINIARS SCREWS received FDA 510(k) clearance on 2016-02-05, under 510(k) number K143596.

Who is the listed applicant for MINIARS SCREWS?

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

What is the FDA product code for MINIARS SCREWS?

The FDA product code for MINIARS SCREWS is HWC. This falls under the Cardiovascular category.

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医療機器の概要

よくある質問

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関連機器（コード：HWC）

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