FDA 510(k)

FITBONE TAA

K 號：K163368 · 2017-01-26

決定日期2017-01-26

產品代碼HSB

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決定相當於

器材摘要

FITBONE TAA is the device name listed in this FDA 510(k) record. The listed applicant is Wittenstein Intens GmbH. It received FDA 510(k) clearance on 2017-01-26 under 510(k) number K163368. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FITBONE TAA?

FITBONE TAA is a medical device that received FDA 510(k) clearance on 2017-01-26. The listed applicant is Wittenstein Intens GmbH. The 510(k) number is K163368.

When did FITBONE TAA receive FDA 510(k) clearance?

FITBONE TAA received FDA 510(k) clearance on 2017-01-26, under 510(k) number K163368.

Who is the listed applicant for FITBONE TAA?

The FDA 510(k) record lists Wittenstein Intens GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FITBONE TAA?

The FDA product code for FITBONE TAA is HSB.

其他以 Wittenstein Intens GmbH 為申請人之記錄

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K203399FITBONE® TAA

相關器械（代碼：HSB）

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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