FDA 510(k)

RIGEL PEEK 頸椎前方椎間融合系統

K 號：K190618 · 2019-06-06

決定日期2019-06-06

產品代碼ODP

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器材摘要

RIGEL PEEK 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 2019-06-06 under 510(k) number K190618. 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 RIGEL PEEK Anterior Cervical Interbody Fusion System?

RIGEL PEEK Anterior Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2019-06-06. The listed applicant is MiRus, LLC. The 510(k) number is K190618.

When did RIGEL PEEK Anterior Cervical Interbody Fusion System receive FDA 510(k) clearance?

RIGEL PEEK Anterior Cervical Interbody Fusion System received FDA 510(k) clearance on 2019-06-06, under 510(k) number K190618.

Who is the listed applicant for RIGEL PEEK 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 PEEK Anterior Cervical Interbody Fusion System?

The FDA product code for RIGEL PEEK Anterior Cervical Interbody Fusion System is ODP.

其他以 MiRus, LLC 為申請人之記錄

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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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