FDA 510(k)

Coronet軟組織固定系統

K 號：K200028 · 2020-03-04

決定日期2020-03-04

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

Coronet Soft Tissue Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Conextions Medical. It received FDA 510(k) clearance on 2020-03-04 under 510(k) number K200028. 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 Coronet Soft Tissue Fixation System?

Coronet Soft Tissue Fixation System is a medical device that received FDA 510(k) clearance on 2020-03-04. The listed applicant is Conextions Medical. The 510(k) number is K200028.

When did Coronet Soft Tissue Fixation System receive FDA 510(k) clearance?

Coronet Soft Tissue Fixation System received FDA 510(k) clearance on 2020-03-04, under 510(k) number K200028.

Who is the listed applicant for Coronet Soft Tissue Fixation System?

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

What is the FDA product code for Coronet Soft Tissue Fixation System?

The FDA product code for Coronet Soft Tissue Fixation System is MBI.

其他以 Conextions Medical 為申請人之記錄

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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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官方來源

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