FDA 510(k)

4CIS®馬林ACIF籠架系統

K 號：K162402 · 2017-02-16

決定日期2017-02-16

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

4CIS® Marlin ACIF Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Solco Biomedical Co., Ltd.. It received FDA 510(k) clearance on 2017-02-16 under 510(k) number K162402. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 4CIS® Marlin ACIF Cage System?

4CIS® Marlin ACIF Cage System is a medical device that received FDA 510(k) clearance on 2017-02-16. The listed applicant is Solco Biomedical Co., Ltd.. The 510(k) number is K162402.

When did 4CIS® Marlin ACIF Cage System receive FDA 510(k) clearance?

4CIS® Marlin ACIF Cage System received FDA 510(k) clearance on 2017-02-16, under 510(k) number K162402.

Who is the listed applicant for 4CIS® Marlin ACIF Cage System?

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

What is the FDA product code for 4CIS® Marlin ACIF Cage System?

The FDA product code for 4CIS® Marlin ACIF Cage System is ODP.

其他以 Solco Biomedical Co., Ltd. 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：ODP）

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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