FDA 510(k)

KONG®-TL VBR 系統及 KONG® C VBR 系統

K 號：K232790 · 2024-04-04

決定日期2024-04-04

產品代碼MQP

諮詢委員會或

決定相當於

器材摘要

KONG®-TL VBR System and KONG® C VBR System is the device name listed in this FDA 510(k) record. The listed applicant is Icotec AG. It received FDA 510(k) clearance on 2024-04-04 under 510(k) number K232790. 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 KONG®-TL VBR System and KONG® C VBR System?

KONG®-TL VBR System and KONG® C VBR System is a medical device that received FDA 510(k) clearance on 2024-04-04. The listed applicant is Icotec AG. The 510(k) number is K232790.

When did KONG®-TL VBR System and KONG® C VBR System receive FDA 510(k) clearance?

KONG®-TL VBR System and KONG® C VBR System received FDA 510(k) clearance on 2024-04-04, under 510(k) number K232790.

Who is the listed applicant for KONG®-TL VBR System and KONG® C VBR System?

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

What is the FDA product code for KONG®-TL VBR System and KONG® C VBR System?

The FDA product code for KONG®-TL VBR System and KONG® C VBR System is MQP.

其他以 Icotec AG 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。

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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.K233359DOMINION可擴展椎體切除系統Astura Medical K231134維特洛克脊椎系統Signature Orthopaedics Pty, Ltd.

官方來源

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