FDA 510(k)

先進研究醫學Trident SI螺釘系統

K 號：K203373 · 2021-01-22

決定日期2021-01-22

產品代碼OUR

諮詢委員會或

決定相當於

器材摘要

Advanced Research Medical Trident SI Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Research Medical, LLC. It received FDA 510(k) clearance on 2021-01-22 under 510(k) number K203373. 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 Advanced Research Medical Trident SI Screw System?

Advanced Research Medical Trident SI Screw System is a medical device that received FDA 510(k) clearance on 2021-01-22. The listed applicant is Advanced Research Medical, LLC. The 510(k) number is K203373.

When did Advanced Research Medical Trident SI Screw System receive FDA 510(k) clearance?

Advanced Research Medical Trident SI Screw System received FDA 510(k) clearance on 2021-01-22, under 510(k) number K203373.

Who is the listed applicant for Advanced Research Medical Trident SI Screw System?

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

What is the FDA product code for Advanced Research Medical Trident SI Screw System?

The FDA product code for Advanced Research Medical Trident SI Screw System is OUR.

其他以 Advanced Research Medical, 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。

K173947腰椎間融合系統（OLLIF）

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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