FDA 510(k)

BePOD® EZ ウェイルスクリュー

K番号: K163710 · 2017-09-08

決定日2017-09-08

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® EZ Weil 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 2017-09-08 under 510(k) number K163710. 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® EZ Weil Screws?

BePOD® EZ Weil Screws is a medical device that received FDA 510(k) clearance on 2017-09-08. The listed applicant is Fournitures Hospitalieres Industrie. The 510(k) number is K163710.

When did BePOD® EZ Weil Screws receive FDA 510(k) clearance?

BePOD® EZ Weil Screws received FDA 510(k) clearance on 2017-09-08, under 510(k) number K163710.

Who is the listed applicant for BePOD® EZ Weil 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® EZ Weil Screws?

The FDA product code for BePOD® EZ Weil 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

K171789ARROW 逆多孔性肩胛窩 K163148BePOD® 足ボルト K162068ARROW 生体組織多孔性肩胛窩 K170040BePOD 穿刺関節融合スクリュー

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