FDA 510(k)

SI-TECHNOLOGY® SI-DESIS® X™ 骨盆釘合系統

K 號：K241813 · 2024-08-13

決定日期2024-08-13

產品代碼OUR

諮詢委員會或

決定相當於

器材摘要

SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Si-Technology, LLC. It received FDA 510(k) clearance on 2024-08-13 under 510(k) number K241813. 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-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System?

SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is a medical device that received FDA 510(k) clearance on 2024-08-13. The listed applicant is Si-Technology, LLC. The 510(k) number is K241813.

When did SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System receive FDA 510(k) clearance?

SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System received FDA 510(k) clearance on 2024-08-13, under 510(k) number K241813.

Who is the listed applicant for SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System?

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

What is the FDA product code for SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System?

The FDA product code for SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is OUR.

其他以 Si-Technology, LLC 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。

K251525SI-TECHNOLOGY® SI-DESIS® X™ 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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