FDA 510(k)

雙重醫用通用脊柱系統

K 號：K151458 · 2016-08-22

決定日期2016-08-22

產品代碼MNI

諮詢委員會或

決定相當於

器材摘要

Double Medical Universal Spine System is the device name listed in this FDA 510(k) record. The listed applicant is Double Medical Technology, Inc.. It received FDA 510(k) clearance on 2016-08-22 under 510(k) number K151458. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Double Medical Universal Spine System?

Double Medical Universal Spine System is a medical device that received FDA 510(k) clearance on 2016-08-22. The listed applicant is Double Medical Technology, Inc.. The 510(k) number is K151458.

When did Double Medical Universal Spine System receive FDA 510(k) clearance?

Double Medical Universal Spine System received FDA 510(k) clearance on 2016-08-22, under 510(k) number K151458.

Who is the listed applicant for Double Medical Universal Spine System?

The FDA 510(k) record lists Double Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Double Medical Universal Spine System?

The FDA product code for Double Medical Universal Spine System is MNI.

其他以 Double Medical Technology, 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。

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相關器械（代碼：MNI）

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。

K171497米克隆脊椎固定系統Mikron Makina Sanayi Ticaret Co. , Ltd.K160731LumFix脊椎固定系統CG Bio Co., Ltd.K153273MySpine脊椎釘道放置導引 - LPMedacta International S.A.K160124LUMIS 穿刺椎板螺釘固定系統，U.L.I.S. 椎板螺釘固定系統Spinevision S.A.K160320預先Shandong Weigao Orthopaedic Device Co., Ltd.K160003Sniper (R)脊椎系統Spine Wave, Inc.

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