FDA 510(k)

內部八合一植入系統

K 號：K170031 · 2017-08-31

決定日期2017-08-31

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

Internal Octa Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Ebi, Inc.. It received FDA 510(k) clearance on 2017-08-31 under 510(k) number K170031. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Internal Octa Implant System?

Internal Octa Implant System is a medical device that received FDA 510(k) clearance on 2017-08-31. The listed applicant is Ebi, Inc.. The 510(k) number is K170031.

When did Internal Octa Implant System receive FDA 510(k) clearance?

Internal Octa Implant System received FDA 510(k) clearance on 2017-08-31, under 510(k) number K170031.

Who is the listed applicant for Internal Octa Implant System?

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

What is the FDA product code for Internal Octa Implant System?

The FDA product code for Internal Octa Implant System is DZE.

其他以 Ebi, Inc. 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。

K190837內置六角植入系統

相關器械（代碼：DZE）

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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