FDA 510(k)

NEX-D2後固定系統

K 號：K190981 · 2020-01-15

決定日期2020-01-15

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

NEX-D2 Posterior Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Next Orthosurgical. It received FDA 510(k) clearance on 2020-01-15 under 510(k) number K190981. 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 NEX-D2 Posterior Fixation System?

NEX-D2 Posterior Fixation System is a medical device that received FDA 510(k) clearance on 2020-01-15. The listed applicant is Next Orthosurgical. The 510(k) number is K190981.

When did NEX-D2 Posterior Fixation System receive FDA 510(k) clearance?

NEX-D2 Posterior Fixation System received FDA 510(k) clearance on 2020-01-15, under 510(k) number K190981.

Who is the listed applicant for NEX-D2 Posterior Fixation System?

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

What is the FDA product code for NEX-D2 Posterior Fixation System?

The FDA product code for NEX-D2 Posterior Fixation System is NKB.

其他以 Next Orthosurgical 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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