FDA 510(k)

MediExpand TL 可擴展 VBR 系統

K 號：K190349 · 2019-10-24

決定日期2019-10-24

產品代碼MQP

諮詢委員會或

決定相當於

器材摘要

MediExpand TL Expandable VBR System is the device name listed in this FDA 510(k) record. The listed applicant is Cmf Medicon Surgical, Inc.. It received FDA 510(k) clearance on 2019-10-24 under 510(k) number K190349. 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 MediExpand TL Expandable VBR System?

MediExpand TL Expandable VBR System is a medical device that received FDA 510(k) clearance on 2019-10-24. The listed applicant is Cmf Medicon Surgical, Inc.. The 510(k) number is K190349.

When did MediExpand TL Expandable VBR System receive FDA 510(k) clearance?

MediExpand TL Expandable VBR System received FDA 510(k) clearance on 2019-10-24, under 510(k) number K190349.

Who is the listed applicant for MediExpand TL Expandable VBR System?

The FDA 510(k) record lists Cmf Medicon Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MediExpand TL Expandable VBR System?

The FDA product code for MediExpand TL Expandable VBR System is MQP.

其他以 Cmf Medicon Surgical, Inc. 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。

K241253美康表皮板系統 K242764MediRod 椎板螺釘系統 K212126MediExpand 頸部擴張式VBR系統

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

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