FDA 510(k)

革命™脊椎固定系統

K 號：K163056 · 2017-02-24

決定日期2017-02-24

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Revolution™ Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Intelligent Implant Systems, LLC. It received FDA 510(k) clearance on 2017-02-24 under 510(k) number K163056. 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 Revolution™ Spinal Fixation System?

Revolution™ Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2017-02-24. The listed applicant is Intelligent Implant Systems, LLC. The 510(k) number is K163056.

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

Revolution™ Spinal Fixation System received FDA 510(k) clearance on 2017-02-24, under 510(k) number K163056.

Who is the listed applicant for Revolution™ Spinal Fixation System?

The FDA 510(k) record lists Intelligent Implant Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Revolution™ Spinal Fixation System?

The FDA product code for Revolution™ Spinal Fixation System is NKB.

其他以 Intelligent Implant Systems, LLC 為申請人之記錄

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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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