FDA 510(k)

iFuse Implant System®

K 號：K182983 · 2018-11-27

決定日期2018-11-27

產品代碼OUR

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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 2018-11-27 under 510(k) number K182983. 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 2018-11-27. The listed applicant is SI-BONE, Inc.. The 510(k) number is K182983.

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

iFuse Implant System® received FDA 510(k) clearance on 2018-11-27, under 510(k) number K182983.

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

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：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。

K261381TiLink-L™ 骨盆聯合融合系統SurGenTec, LLC K260477CATAMARAN™ 骨盆聯合融合系統Tenon Medical K253488iFuse INTRA Ti™ 嵌入系統SI-BONE, Inc.K253611鷹融合系統Mcnicoll Surgical, Inc.K252834骨盆釘合系統 (SJTS)4Web Medical K251365OptumSI 嵌入式系統Si Solutions, LLC

官方來源

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