FDA 510(k)

F3D 間體系統

K 號：K230329 · 2023-06-06

決定日期2023-06-06

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

F3D Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Corelink, LLC. It received FDA 510(k) clearance on 2023-06-06 under 510(k) number K230329. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the F3D Interbody System?

F3D Interbody System is a medical device that received FDA 510(k) clearance on 2023-06-06. The listed applicant is Corelink, LLC. The 510(k) number is K230329.

When did F3D Interbody System receive FDA 510(k) clearance?

F3D Interbody System received FDA 510(k) clearance on 2023-06-06, under 510(k) number K230329.

Who is the listed applicant for F3D Interbody System?

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

What is the FDA product code for F3D Interbody System?

The FDA product code for F3D Interbody System is ODP.

其他以 Corelink, LLC 為申請人之記錄

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相關器械（代碼：ODP）

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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