FDA 510(k)

DTRAX脊椎系統

K 號：K180876 · 2018-05-18

決定日期2018-05-18

產品代碼HRX

諮詢委員會或

決定相當於

器材摘要

DTRAX Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Providence Medical Technology, Inc.. It received FDA 510(k) clearance on 2018-05-18 under 510(k) number K180876. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DTRAX Spinal System?

DTRAX Spinal System is a medical device that received FDA 510(k) clearance on 2018-05-18. The listed applicant is Providence Medical Technology, Inc.. The 510(k) number is K180876.

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

DTRAX Spinal System received FDA 510(k) clearance on 2018-05-18, under 510(k) number K180876.

Who is the listed applicant for DTRAX Spinal System?

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

What is the FDA product code for DTRAX Spinal System?

The FDA product code for DTRAX Spinal System is HRX.

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

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K261665CORUS™導航系統-GN K253676CORUS™ 頸後穩定系統 3D (CORUS™ PCSS 3D)K253190CORUS-LX 假體 K251060CORUS™導航系統-GX K251885CAVUX 閃骨固定系統（CAVUX FFS）及 CORUS-LX 假體 K241035PMT後頸穩定系統（PCSS）

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相關器械（代碼：HRX）

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。

K260203富麗椎體成形術氣球針管Beijing Fule Science & Technology Development Co., Ltd.K254103霍普金斯內視鏡術望遠鏡Karl Storz SE & CO. KG K252790數位ClarusScope系統及數位NeuroPEN系統Clarus Medical, LLC K253523Freedom DS™ 解壓系統Spinal Simplicity K252546Vantage™ 腰椎减压套件Allevion Medical, LLC K253217MiiS Horus 鼻喉鏡 (EJA 100)；MiiS Horus 結腸鏡顯示系統 - 平板 (EDS 500)；MiiS Horus 結腸鏡顯示系統 - 遙控盒 (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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