FDA 510(k)

SI-Restore 骨盆釘合系統

K 號：K200868 · 2020-04-17

決定日期2020-04-17

產品代碼OUR

諮詢委員會或

決定相當於

器材摘要

SI-Restore Sacroiliac Joint Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Biofusion Medical. It received FDA 510(k) clearance on 2020-04-17 under 510(k) number K200868. 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-Restore Sacroiliac Joint Fixation System?

SI-Restore Sacroiliac Joint Fixation System is a medical device that received FDA 510(k) clearance on 2020-04-17. The listed applicant is Biofusion Medical. The 510(k) number is K200868.

When did SI-Restore Sacroiliac Joint Fixation System receive FDA 510(k) clearance?

SI-Restore Sacroiliac Joint Fixation System received FDA 510(k) clearance on 2020-04-17, under 510(k) number K200868.

Who is the listed applicant for SI-Restore Sacroiliac Joint Fixation System?

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

What is the FDA product code for SI-Restore Sacroiliac Joint Fixation System?

The FDA product code for SI-Restore Sacroiliac Joint Fixation System is OUR.

其他以 Biofusion 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。

K182919SI-Restore® 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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