FDA 510(k)

BePOD 穿刺関節融合スクリュー

K番号: K170040 · 2017-04-04

決定日2017-04-04

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

BePOD Cannulated Arthrodesis Screws is the device name listed in this FDA 510(k) record. The listed applicant is Fournitures Hospitalieres Industrie. It received FDA 510(k) clearance on 2017-04-04 under 510(k) number K170040. 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 BePOD Cannulated Arthrodesis Screws?

BePOD Cannulated Arthrodesis Screws is a medical device that received FDA 510(k) clearance on 2017-04-04. The listed applicant is Fournitures Hospitalieres Industrie. The 510(k) number is K170040.

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

BePOD Cannulated Arthrodesis Screws received FDA 510(k) clearance on 2017-04-04, under 510(k) number K170040.

Who is the listed applicant for BePOD Cannulated Arthrodesis Screws?

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

What is the FDA product code for BePOD Cannulated Arthrodesis Screws?

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

申請者としてFournitures Hospitalieres Industrieを記載するその他の記録

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