FDA 510(k)

Rexious脊椎固定系統

K 號：K173131 · 2017-12-08

決定日期2017-12-08

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Rexious Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Huvexel Co. , Ltd.. It received FDA 510(k) clearance on 2017-12-08 under 510(k) number K173131. 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 Rexious Spinal Fixation System?

Rexious Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2017-12-08. The listed applicant is Huvexel Co. , Ltd.. The 510(k) number is K173131.

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

Rexious Spinal Fixation System received FDA 510(k) clearance on 2017-12-08, under 510(k) number K173131.

Who is the listed applicant for Rexious Spinal Fixation System?

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

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

The FDA product code for Rexious Spinal Fixation System is NKB.

其他以 Huvexel Co. , Ltd. 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。

K213820BALTEUM - ONE™ 椎板系統 K200846Balteum™ 腰椎板系統 K191477AEON-C 独立系統 K180729法塞固定系統 K173201UNITY 骨盆釘合系統 K173099福蒂斯與漢娜前頸椎板系統

查看所有 8 項裝置 →

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。