FDA 510(k)

カニュレートド・スクリューネオオルソ

K番号: K162874 · 2017-06-27

決定日2017-06-27

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

Cannulated Screws Neoortho is the device name listed in this FDA 510(k) record. The listed applicant is Neoortho Produtos Ortopedicos S/A. It received FDA 510(k) clearance on 2017-06-27 under 510(k) number K162874. 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 Cannulated Screws Neoortho?

Cannulated Screws Neoortho is a medical device that received FDA 510(k) clearance on 2017-06-27. The listed applicant is Neoortho Produtos Ortopedicos S/A. The 510(k) number is K162874.

When did Cannulated Screws Neoortho receive FDA 510(k) clearance?

Cannulated Screws Neoortho received FDA 510(k) clearance on 2017-06-27, under 510(k) number K162874.

Who is the listed applicant for Cannulated Screws Neoortho?

The FDA 510(k) record lists Neoortho Produtos Ortopedicos S/A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cannulated Screws Neoortho?

The FDA product code for Cannulated Screws Neoortho is HWC. This falls under the Cardiovascular category.

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カニュレートド・スクリューネオオルソ

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：HWC）

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