FDA 510(k)

德金醫療 E3 MIS 椎板釘系統

K 號：K173814 · 2018-01-29

決定日期2018-01-29

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

DeGen Medical E3 MIS Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Degen Medical. It received FDA 510(k) clearance on 2018-01-29 under 510(k) number K173814. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DeGen Medical E3 MIS Pedicle Screw System?

DeGen Medical E3 MIS Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2018-01-29. The listed applicant is Degen Medical. The 510(k) number is K173814.

When did DeGen Medical E3 MIS Pedicle Screw System receive FDA 510(k) clearance?

DeGen Medical E3 MIS Pedicle Screw System received FDA 510(k) clearance on 2018-01-29, under 510(k) number K173814.

Who is the listed applicant for DeGen Medical E3 MIS Pedicle Screw System?

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

What is the FDA product code for DeGen Medical E3 MIS Pedicle Screw System?

The FDA product code for DeGen Medical E3 MIS Pedicle Screw System is NKB.

其他以 Degen Medical 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：NKB）

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。

K252139肯特羅斯賓 Viktr-MIS® 椎板螺釘系統Rivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ 假骨植入系統SI-BONE, Inc.K262091FRAXION脊椎固定系統Ortler Global Tibbi Gerecler Anonim Sirketi K262193RIVA® 後固定系統搭配NanoACTIV表面技術；RIVA® 髋骨結合固定釘搭配NanoACTIV表面技術Xenix Medical K262828KHEIRON®脊椎固定系統，包括客製化K-RODS.M.A.I.O K260362QUATTRO脊椎系統（開放配置）；QUATTRO-GADGET脊椎系統（MIS配置）MANTIZ Co., Ltd.

官方來源

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