FDA 510(k)

維特福後固定系統

K 號：K161499 · 2016-07-29

決定日期2016-07-29

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

VertiForm 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 2016-07-29 under 510(k) number K161499. 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 VertiForm Posterior Fixation System?

VertiForm Posterior Fixation System is a medical device that received FDA 510(k) clearance on 2016-07-29. The listed applicant is Next Orthosurgical. The 510(k) number is K161499.

When did VertiForm Posterior Fixation System receive FDA 510(k) clearance?

VertiForm Posterior Fixation System received FDA 510(k) clearance on 2016-07-29, under 510(k) number K161499.

Who is the listed applicant for VertiForm 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 VertiForm Posterior Fixation System?

The FDA product code for VertiForm 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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官方來源

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