FDA 510(k)

MONDRIAN 腰椎間融合金層系統

K 號：K192863 · 2020-08-26

決定日期2020-08-26

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

MONDRIAN Lumbar Interbody Fusion Cage System 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 2020-08-26 under 510(k) number K192863. 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 MONDRIAN Lumbar Interbody Fusion Cage System?

MONDRIAN Lumbar Interbody Fusion Cage System is a medical device that received FDA 510(k) clearance on 2020-08-26. The listed applicant is Ctl Medical Corporation. The 510(k) number is K192863.

When did MONDRIAN Lumbar Interbody Fusion Cage System receive FDA 510(k) clearance?

MONDRIAN Lumbar Interbody Fusion Cage System received FDA 510(k) clearance on 2020-08-26, under 510(k) number K192863.

Who is the listed applicant for MONDRIAN Lumbar Interbody Fusion Cage System?

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 MONDRIAN Lumbar Interbody Fusion Cage System?

The FDA product code for MONDRIAN Lumbar Interbody Fusion Cage System is MAX.

其他以 Ctl Medical Corporation 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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官方來源

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