FDA 510(k)

Irix-C 頸椎整合融合系統

K 號：K162944 · 2016-11-07

決定日期2016-11-07

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

Irix-C Cervical Integrated Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2016-11-07 under 510(k) number K162944. 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 Irix-C Cervical Integrated Fusion System?

Irix-C Cervical Integrated Fusion System is a medical device that received FDA 510(k) clearance on 2016-11-07. The listed applicant is X-Spine Systems, Inc.. The 510(k) number is K162944.

When did Irix-C Cervical Integrated Fusion System receive FDA 510(k) clearance?

Irix-C Cervical Integrated Fusion System received FDA 510(k) clearance on 2016-11-07, under 510(k) number K162944.

Who is the listed applicant for Irix-C Cervical Integrated Fusion System?

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

What is the FDA product code for Irix-C Cervical Integrated Fusion System?

The FDA product code for Irix-C Cervical Integrated Fusion System is OVE.

其他以 X-Spine Systems, Inc. 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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