FDA 510(k)

Virtu C脊椎植入系統

K 號：K161649 · 2016-11-09

決定日期2016-11-09

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

Virtu C Spinal Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Met 1 Technologies, LLC. It received FDA 510(k) clearance on 2016-11-09 under 510(k) number K161649. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Virtu C Spinal Implant System?

Virtu C Spinal Implant System is a medical device that received FDA 510(k) clearance on 2016-11-09. The listed applicant is Met 1 Technologies, LLC. The 510(k) number is K161649.

When did Virtu C Spinal Implant System receive FDA 510(k) clearance?

Virtu C Spinal Implant System received FDA 510(k) clearance on 2016-11-09, under 510(k) number K161649.

Who is the listed applicant for Virtu C Spinal Implant System?

The FDA 510(k) record lists Met 1 Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Virtu C Spinal Implant System?

The FDA product code for Virtu C Spinal Implant System is ODP.

其他以 Met 1 Technologies, LLC 為申請人之記錄

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K160699VIRTU 腰椎間隔系統

相關器械（代碼：ODP）

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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