FDA 510(k)

皮質固定系統

K 號：K181086 · 2019-01-09

決定日期2019-01-09

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

Cortical Fixation Systems is the device name listed in this FDA 510(k) record. The listed applicant is Cousin Biotech Sas. It received FDA 510(k) clearance on 2019-01-09 under 510(k) number K181086. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cortical Fixation Systems?

Cortical Fixation Systems is a medical device that received FDA 510(k) clearance on 2019-01-09. The listed applicant is Cousin Biotech Sas. The 510(k) number is K181086.

When did Cortical Fixation Systems receive FDA 510(k) clearance?

Cortical Fixation Systems received FDA 510(k) clearance on 2019-01-09, under 510(k) number K181086.

Who is the listed applicant for Cortical Fixation Systems?

The FDA 510(k) record lists Cousin Biotech Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cortical Fixation Systems?

The FDA product code for Cortical Fixation Systems is MBI.

其他以 Cousin Biotech Sas 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：MBI）

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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