FDA 510(k)

雙重醫用股骨釘系統

K 號：K172830 · 2018-08-24

決定日期2018-08-24

產品代碼HSB

諮詢委員會或

決定相當於

器材摘要

Double Medical Femoral Nail 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 2018-08-24 under 510(k) number K172830. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Double Medical Femoral Nail System?

Double Medical Femoral Nail System is a medical device that received FDA 510(k) clearance on 2018-08-24. The listed applicant is Double Medical Technology, Inc.. The 510(k) number is K172830.

When did Double Medical Femoral Nail System receive FDA 510(k) clearance?

Double Medical Femoral Nail System received FDA 510(k) clearance on 2018-08-24, under 510(k) number K172830.

Who is the listed applicant for Double Medical Femoral Nail 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 Femoral Nail System?

The FDA product code for Double Medical Femoral Nail System is HSB.

其他以 Double Medical Technology, Inc. 為申請人之記錄

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相關器械（代碼：HSB）

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。

K261345兒童釘針平台髋骨OrthoPediatrics Corp.K261481Pangea 髋骨重建系統Stryker GmbH K253080AND 医療股骨釘系統 (PFNA01); AND 医療股骨釘系統 (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max 系統及 Precice™ 腳踝挽救系統NuVasive Specialized Orthopedics K253155富麗金屬可鎖定內骨髓釘系統Beijing Fule Science & Technology Development Co., Ltd.K253046HERA 開合式硬脊釘系統ZheJiang Decans Medical Devices Co., Ltd.

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