FDA 510(k)

REUNION 骨盆釘合系統

K 號：K232211 · 2023-10-24

決定日期2023-10-24

產品代碼OUR

諮詢委員會或

決定相當於

器材摘要

REUNION Sacroiliac Joint Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Astura Medical. It received FDA 510(k) clearance on 2023-10-24 under 510(k) number K232211. 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 REUNION Sacroiliac Joint Fusion System?

REUNION Sacroiliac Joint Fusion System is a medical device that received FDA 510(k) clearance on 2023-10-24. The listed applicant is Astura Medical. The 510(k) number is K232211.

When did REUNION Sacroiliac Joint Fusion System receive FDA 510(k) clearance?

REUNION Sacroiliac Joint Fusion System received FDA 510(k) clearance on 2023-10-24, under 510(k) number K232211.

Who is the listed applicant for REUNION Sacroiliac Joint Fusion System?

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

What is the FDA product code for REUNION Sacroiliac Joint Fusion System?

The FDA product code for REUNION Sacroiliac Joint Fusion System is OUR.

其他以 Astura Medical 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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