FDA 510(k)

Vitoss 生物活性（BA）注射劑

K 號：K163621 · 2017-05-02

決定日期2017-05-02

產品代碼MQV

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決定相當於

器材摘要

Vitoss Bioactive (BA) Injectable is the device name listed in this FDA 510(k) record. The listed applicant is Orthovita, Inc.. It received FDA 510(k) clearance on 2017-05-02 under 510(k) number K163621. 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 Vitoss Bioactive (BA) Injectable?

Vitoss Bioactive (BA) Injectable is a medical device that received FDA 510(k) clearance on 2017-05-02. The listed applicant is Orthovita, Inc.. The 510(k) number is K163621.

When did Vitoss Bioactive (BA) Injectable receive FDA 510(k) clearance?

Vitoss Bioactive (BA) Injectable received FDA 510(k) clearance on 2017-05-02, under 510(k) number K163621.

Who is the listed applicant for Vitoss Bioactive (BA) Injectable?

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 Vitoss Bioactive (BA) Injectable?

The FDA product code for Vitoss Bioactive (BA) Injectable 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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