FDA 510(k)

NuVasive® VersaTie™ 系統

K 號：K173117 · 2017-12-07

決定日期2017-12-07

產品代碼OWI

諮詢委員會或

決定相當於

器材摘要

NuVasive® VersaTie™ System is the device name listed in this FDA 510(k) record. The listed applicant is Nuvasive, Inc.. It received FDA 510(k) clearance on 2017-12-07 under 510(k) number K173117. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NuVasive® VersaTie™ System?

NuVasive® VersaTie™ System is a medical device that received FDA 510(k) clearance on 2017-12-07. The listed applicant is Nuvasive, Inc.. The 510(k) number is K173117.

When did NuVasive® VersaTie™ System receive FDA 510(k) clearance?

NuVasive® VersaTie™ System received FDA 510(k) clearance on 2017-12-07, under 510(k) number K173117.

Who is the listed applicant for NuVasive® VersaTie™ System?

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

What is the FDA product code for NuVasive® VersaTie™ System?

The FDA product code for NuVasive® VersaTie™ System is OWI.

其他以 Nuvasive, Inc. 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：OWI）

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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