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FDA 510(k)

CD HORIZON®脊椎系統，與IPC® POWEREASE®系統配合使用的Medtronic可重用儀器，與STEALTHSTATION®及IPC® POWEREASE®系統配合使用的Medtronic導航可重用儀器

K 號：K170679 · 2017-05-11

申請人Medtronic Sofamor Danek
決定日期2017-05-11
產品代碼NKB
諮詢委員會或
決定相當於

器材摘要

CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2017-05-11 under 510(k) number K170679. 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 CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems?

CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems is a medical device that received FDA 510(k) clearance on 2017-05-11. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K170679.

When did CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems receive FDA 510(k) clearance?

CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems received FDA 510(k) clearance on 2017-05-11, under 510(k) number K170679.

Who is the listed applicant for CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems?

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

What is the FDA product code for CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems?

The FDA product code for CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems is NKB.

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

其他以 Medtronic Sofamor Danek 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。

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官方來源

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