FDA 510(k)

iFuse Bedrock Granite™ 假骨塊植入系統

K 號：K220195 · 2022-05-26

決定日期2022-05-26

產品代碼OUR

諮詢委員會或

決定相當於

器材摘要

iFuse Bedrock Granite™ 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 2022-05-26 under 510(k) number K220195. 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 Bedrock Granite™ Implant System?

iFuse Bedrock Granite™ Implant System is a medical device that received FDA 510(k) clearance on 2022-05-26. The listed applicant is SI-BONE, Inc.. The 510(k) number is K220195.

When did iFuse Bedrock Granite™ Implant System receive FDA 510(k) clearance?

iFuse Bedrock Granite™ Implant System received FDA 510(k) clearance on 2022-05-26, under 510(k) number K220195.

Who is the listed applicant for iFuse Bedrock Granite™ 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 Bedrock Granite™ Implant System?

The FDA product code for iFuse Bedrock Granite™ 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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