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FDA 510(k)

MONET 前頸間融合金屬內置架系統附設補充固定板

K 號：K182151 · 2018-10-11

申請人Ctl Medical Corporation
決定日期2018-10-11
產品代碼OVE
諮詢委員會或
決定相當於

器材摘要

MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate is the device name listed in this FDA 510(k) record. The listed applicant is Ctl Medical Corporation. It received FDA 510(k) clearance on 2018-10-11 under 510(k) number K182151. 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 MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate?

MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate is a medical device that received FDA 510(k) clearance on 2018-10-11. The listed applicant is Ctl Medical Corporation. The 510(k) number is K182151.

When did MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate receive FDA 510(k) clearance?

MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate received FDA 510(k) clearance on 2018-10-11, under 510(k) number K182151.

Who is the listed applicant for MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate?

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

What is the FDA product code for MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate?

The FDA product code for MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate is OVE.

相關臨床試驗

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其他以 Ctl Medical Corporation 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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