FDA 510(k)

F3D 胸骨切除系統

K 號：K202637 · 2020-12-23

決定日期2020-12-23

產品代碼MQP

諮詢委員會或

決定相當於

器材摘要

F3D Corpectomy 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 2020-12-23 under 510(k) number K202637. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the F3D Corpectomy System?

F3D Corpectomy System is a medical device that received FDA 510(k) clearance on 2020-12-23. The listed applicant is Corelink, LLC. The 510(k) number is K202637.

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

F3D Corpectomy System received FDA 510(k) clearance on 2020-12-23, under 510(k) number K202637.

Who is the listed applicant for F3D Corpectomy 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 Corpectomy System?

The FDA product code for F3D Corpectomy System is MQP.

其他以 Corelink, 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。

K231743F3D 横向腰椎椎間系統，CL5 横向腰椎椎間系統，以及Oro 横向板系統 K231494CoreLink機械導航儀器 K232116核心鏈導航儀器 K230329F3D 間體系統 K230880核心鏈導航儀器 K223708Entasis 3D雙導電骨盆釘植入系統

查看所有 23 項裝置 →

相關器械（代碼：MQP）

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。

K261810維蒂威奇® 骨內系統Foundation Surgical Group K261031波塞冬STSignus Medinzintechnik GmbH K253158VyBrate™ VBR 系統Vy Spine, LLC K241468維蒂威奇® 骨內系統Foundation Surgical Group, Inc.K232790KONG®-TL VBR 系統及 KONG® C VBR 系統Icotec AG K233359DOMINION可擴展椎體切除系統Astura Medical

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。