FDA 510(k)

iFuse Implant System - iFuse導航系統

K 號：K203110 · 2020-11-09

決定日期2020-11-09

產品代碼OLO

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

iFuse Implant System - iFuse Navigation is the device name listed in this FDA 510(k) record. The listed applicant is SI-BONE, Inc.. It received FDA 510(k) clearance on 2020-11-09 under 510(k) number K203110. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the iFuse Implant System - iFuse Navigation?

iFuse Implant System - iFuse Navigation is a medical device that received FDA 510(k) clearance on 2020-11-09. The listed applicant is SI-BONE, Inc.. The 510(k) number is K203110.

When did iFuse Implant System - iFuse Navigation receive FDA 510(k) clearance?

iFuse Implant System - iFuse Navigation received FDA 510(k) clearance on 2020-11-09, under 510(k) number K203110.

Who is the listed applicant for iFuse Implant System - iFuse Navigation?

FDA 510(k) 記錄將 SI-BONE, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for iFuse Implant System - iFuse Navigation?

The FDA product code for iFuse Implant System - iFuse Navigation is OLO.

其他以 SI-BONE, Inc. 為申請人之記錄

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相關器械（代碼：OLO）

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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