FDA 510(k)

Luna 3D 間體融合系統

K 號：K162431 · 2016-11-17

決定日期2016-11-17

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Luna 3D Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Benvenue Medical, Inc.. It received FDA 510(k) clearance on 2016-11-17 under 510(k) number K162431. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Luna 3D Interbody Fusion System?

Luna 3D Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Benvenue Medical, Inc.. The 510(k) number is K162431.

When did Luna 3D Interbody Fusion System receive FDA 510(k) clearance?

Luna 3D Interbody Fusion System received FDA 510(k) clearance on 2016-11-17, under 510(k) number K162431.

Who is the listed applicant for Luna 3D Interbody Fusion System?

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

What is the FDA product code for Luna 3D Interbody Fusion System?

The FDA product code for Luna 3D Interbody Fusion System is MAX.

其他以 Benvenue Medical, Inc. 為申請人之記錄

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相關器械（代碼：MAX）

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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