FDA 510(k)

Fixone 生物複合小釘

K 號：K192032 · 2020-03-03

決定日期2020-03-03

產品代碼MAI

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決定相當於

器材摘要

Fixone Biocomposite Small Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Aju Pharm Co., Ltd.. It received FDA 510(k) clearance on 2020-03-03 under 510(k) number K192032. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Fixone Biocomposite Small Anchor?

Fixone Biocomposite Small Anchor is a medical device that received FDA 510(k) clearance on 2020-03-03. The listed applicant is Aju Pharm Co., Ltd.. The 510(k) number is K192032.

When did Fixone Biocomposite Small Anchor receive FDA 510(k) clearance?

Fixone Biocomposite Small Anchor received FDA 510(k) clearance on 2020-03-03, under 510(k) number K192032.

Who is the listed applicant for Fixone Biocomposite Small Anchor?

The FDA 510(k) record lists Aju Pharm Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fixone Biocomposite Small Anchor?

The FDA product code for Fixone Biocomposite Small Anchor is MAI.

其他以 Aju Pharm Co., Ltd. 為申請人之記錄

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相關器械（代碼：MAI）

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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