FDA 510(k)

針筒型半植入體

K 號：K190543 · 2019-05-31

決定日期2019-05-31

產品代碼KWD

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決定相當於

器材摘要

Cannulated Hemi Implant is the device name listed in this FDA 510(k) record. The listed applicant is Vilex IN Tennessee, Inc.. It received FDA 510(k) clearance on 2019-05-31 under 510(k) number K190543. The device is classified under product code KWD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cannulated Hemi Implant?

Cannulated Hemi Implant is a medical device that received FDA 510(k) clearance on 2019-05-31. The listed applicant is Vilex IN Tennessee, Inc.. The 510(k) number is K190543.

When did Cannulated Hemi Implant receive FDA 510(k) clearance?

Cannulated Hemi Implant received FDA 510(k) clearance on 2019-05-31, under 510(k) number K190543.

Who is the listed applicant for Cannulated Hemi Implant?

The FDA 510(k) record lists Vilex IN Tennessee, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cannulated Hemi Implant?

The FDA product code for Cannulated Hemi Implant is KWD.

其他以 Vilex IN Tennessee, Inc. 為申請人之記錄

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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相關器械（代碼：KWD）

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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