FDA 510(k)

Velofix™ SA 頸椎籠

K 號：K172424 · 2017-11-22

決定日期2017-11-22

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

Velofix™ SA Cervical Cage is the device name listed in this FDA 510(k) record. The listed applicant is U&I Corporation. It received FDA 510(k) clearance on 2017-11-22 under 510(k) number K172424. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Velofix™ SA Cervical Cage?

Velofix™ SA Cervical Cage is a medical device that received FDA 510(k) clearance on 2017-11-22. The listed applicant is U&I Corporation. The 510(k) number is K172424.

When did Velofix™ SA Cervical Cage receive FDA 510(k) clearance?

Velofix™ SA Cervical Cage received FDA 510(k) clearance on 2017-11-22, under 510(k) number K172424.

Who is the listed applicant for Velofix™ SA Cervical Cage?

The FDA 510(k) record lists U&I Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Velofix™ SA Cervical Cage?

The FDA product code for Velofix™ SA Cervical Cage is OVE.

其他以 U&I Corporation 為申請人之記錄

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相關器械（代碼：OVE）

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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