FDA 510(k)

SI-Cure 骨盆釘合系統

K 號：K223819 · 2023-01-18

決定日期2023-01-18

產品代碼OUR

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決定相當於

器材摘要

SI-Cure Sacroiliac Joint Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Alevio, LLC. It received FDA 510(k) clearance on 2023-01-18 under 510(k) number K223819. 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 SI-Cure Sacroiliac Joint Fusion System?

SI-Cure Sacroiliac Joint Fusion System is a medical device that received FDA 510(k) clearance on 2023-01-18. The listed applicant is Alevio, LLC. The 510(k) number is K223819.

When did SI-Cure Sacroiliac Joint Fusion System receive FDA 510(k) clearance?

SI-Cure Sacroiliac Joint Fusion System received FDA 510(k) clearance on 2023-01-18, under 510(k) number K223819.

Who is the listed applicant for SI-Cure Sacroiliac Joint Fusion System?

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

What is the FDA product code for SI-Cure Sacroiliac Joint Fusion System?

The FDA product code for SI-Cure Sacroiliac Joint Fusion System is OUR.

其他以 Alevio, LLC 為申請人之記錄

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K231951SI-Cure 骨盆釘合系統

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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