FDA 510(k)

TransLoc 3D

K 號：K232878 · 2023-10-17

申請人Foundation Fusion Solutions, LLC (Dba Cornerloc)

決定日期2023-10-17

產品代碼OUR

諮詢委員會或

決定相當於

器材摘要

TransLoc 3D is the device name listed in this FDA 510(k) record. The listed applicant is Foundation Fusion Solutions, LLC (Dba Cornerloc). It received FDA 510(k) clearance on 2023-10-17 under 510(k) number K232878. 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 TransLoc 3D?

TransLoc 3D is a medical device that received FDA 510(k) clearance on 2023-10-17. The listed applicant is Foundation Fusion Solutions, LLC (Dba Cornerloc). The 510(k) number is K232878.

When did TransLoc 3D receive FDA 510(k) clearance?

TransLoc 3D received FDA 510(k) clearance on 2023-10-17, under 510(k) number K232878.

Who is the listed applicant for TransLoc 3D?

The FDA 510(k) record lists Foundation Fusion Solutions, LLC (Dba Cornerloc) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TransLoc 3D?

The FDA product code for TransLoc 3D is OUR.

其他以 Foundation Fusion Solutions, LLC (Dba Cornerloc) 為申請人之記錄

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K211496TransLoc 3D

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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