FDA 510(k)

iFUSE 嵌入式系統

K 號：K160652 · 2016-06-03

決定日期2016-06-03

產品代碼OUR

諮詢委員會或

決定相當於

器材摘要

iFUSE Implant System 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 2016-06-03 under 510(k) number K160652. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the iFUSE Implant System?

iFUSE Implant System is a medical device that received FDA 510(k) clearance on 2016-06-03. The listed applicant is SI-BONE, Inc.. The 510(k) number is K160652.

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

iFUSE Implant System received FDA 510(k) clearance on 2016-06-03, under 510(k) number K160652.

Who is the listed applicant for iFUSE Implant System?

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?

The FDA product code for iFUSE Implant System is OUR.

其他以 SI-BONE, Inc. 為申請人之記錄

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相關器械（代碼：OUR）

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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