FDA 510(k)

RIGEL™ 3DR 独立式前方颈椎椎間融合系統

K 號：K232348 · 2023-10-27

決定日期2023-10-27

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is MiRus, LLC. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K232348. 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 RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System?

RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is MiRus, LLC. The 510(k) number is K232348.

When did RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System receive FDA 510(k) clearance?

RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System received FDA 510(k) clearance on 2023-10-27, under 510(k) number K232348.

Who is the listed applicant for RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System?

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

What is the FDA product code for RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System?

The FDA product code for RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is OVE.

其他以 MiRus, LLC 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：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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官方來源

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