FDA 510(k)

MediExpand 頸部擴張式VBR系統

K 號：K212126 · 2022-04-04

決定日期2022-04-04

產品代碼PLR

諮詢委員會或

決定相當於

器材摘要

MediExpand Cervical 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 2022-04-04 under 510(k) number K212126. The device is classified under product code PLR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MediExpand Cervical Expandable VBR System?

MediExpand Cervical Expandable VBR System is a medical device that received FDA 510(k) clearance on 2022-04-04. The listed applicant is Cmf Medicon Surgical, Inc.. The 510(k) number is K212126.

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

MediExpand Cervical Expandable VBR System received FDA 510(k) clearance on 2022-04-04, under 510(k) number K212126.

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

The FDA product code for MediExpand Cervical Expandable VBR System is PLR.

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 K190349MediExpand TL 可擴展 VBR 系統

相關器械（代碼：PLR）

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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