FDA 510(k)

藍寶石盆骨關節螺釘系統

K 號：K213590 · 2022-03-01

決定日期2022-03-01

產品代碼OUR

諮詢委員會或

決定相當於

器材摘要

Blue Topaz Sacroiliac Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Osseus Fusion Systems, LLC. It received FDA 510(k) clearance on 2022-03-01 under 510(k) number K213590. 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 Blue Topaz Sacroiliac Screw System?

Blue Topaz Sacroiliac Screw System is a medical device that received FDA 510(k) clearance on 2022-03-01. The listed applicant is Osseus Fusion Systems, LLC. The 510(k) number is K213590.

When did Blue Topaz Sacroiliac Screw System receive FDA 510(k) clearance?

Blue Topaz Sacroiliac Screw System received FDA 510(k) clearance on 2022-03-01, under 510(k) number K213590.

Who is the listed applicant for Blue Topaz Sacroiliac Screw System?

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

What is the FDA product code for Blue Topaz Sacroiliac Screw System?

The FDA product code for Blue Topaz Sacroiliac Screw System is OUR.

其他以 Osseus Fusion Systems, LLC 為申請人之記錄

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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。

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官方來源

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