FDA 510(k)

BePOD® EZ Weil 钉子

K 號：K163710 · 2017-09-08

決定日期2017-09-08

產品代碼HWC

諮詢委員會或

決定相當於

器材摘要

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.

常見問題

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.

其他以 Fournitures Hospitalieres Industrie 為申請人之記錄

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相關器械（代碼：HWC）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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