FDA 510(k)

ProMIS™ 固定系統

K 號：K170061 · 2017-02-02

決定日期2017-02-02

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

ProMIS™ Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Premia Spine, Ltd.. It received FDA 510(k) clearance on 2017-02-02 under 510(k) number K170061. 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 ProMIS™ Fixation System?

ProMIS™ Fixation System is a medical device that received FDA 510(k) clearance on 2017-02-02. The listed applicant is Premia Spine, Ltd.. The 510(k) number is K170061.

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

ProMIS™ Fixation System received FDA 510(k) clearance on 2017-02-02, under 510(k) number K170061.

Who is the listed applicant for ProMIS™ Fixation System?

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

What is the FDA product code for ProMIS™ Fixation System?

The FDA product code for ProMIS™ Fixation System is NKB.

其他以 Premia Spine, 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。

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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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