FDA 510(k)

HydroSet XT

K 號：K161447 · 2016-10-06

決定日期2016-10-06

產品代碼MQV

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決定相當於

器材摘要

HydroSet XT is the device name listed in this FDA 510(k) record. The listed applicant is Orthovita, Inc.. It received FDA 510(k) clearance on 2016-10-06 under 510(k) number K161447. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HydroSet XT?

HydroSet XT is a medical device that received FDA 510(k) clearance on 2016-10-06. The listed applicant is Orthovita, Inc.. The 510(k) number is K161447.

When did HydroSet XT receive FDA 510(k) clearance?

HydroSet XT received FDA 510(k) clearance on 2016-10-06, under 510(k) number K161447.

Who is the listed applicant for HydroSet XT?

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

What is the FDA product code for HydroSet XT?

The FDA product code for HydroSet XT is MQV.

其他以 Orthovita, 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：MQV）

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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