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FDA 510(k)

米克隆脊椎固定系統

K 號：K171497 · 2017-10-12

申請人Mikron Makina Sanayi Ticaret Co. , Ltd.
決定日期2017-10-12
產品代碼MNI
諮詢委員會或
決定相當於

器材摘要

Mikron Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Mikron Makina Sanayi Ticaret Co. , Ltd.. It received FDA 510(k) clearance on 2017-10-12 under 510(k) number K171497. 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 Mikron Spinal Fixation System?

Mikron Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2017-10-12. The listed applicant is Mikron Makina Sanayi Ticaret Co. , Ltd.. The 510(k) number is K171497.

When did Mikron Spinal Fixation System receive FDA 510(k) clearance?

Mikron Spinal Fixation System received FDA 510(k) clearance on 2017-10-12, under 510(k) number K171497.

Who is the listed applicant for Mikron Spinal Fixation System?

The FDA 510(k) record lists Mikron Makina Sanayi Ticaret Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mikron Spinal Fixation System?

The FDA product code for Mikron Spinal Fixation System is MNI.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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。

K160731LumFix脊椎固定系統CG Bio Co., Ltd.K151458雙重醫用通用脊柱系統Double Medical Technology, Inc.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.

官方來源

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