FDA 510(k)

CoRoent® Ti-C 系統

K 號：K160916 · 2016-06-28

決定日期2016-06-28

產品代碼MAX

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器材摘要

CoRoent® Ti-C System is the device name listed in this FDA 510(k) record. The listed applicant is Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2016-06-28 under 510(k) number K160916. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CoRoent® Ti-C System?

CoRoent® Ti-C System is a medical device that received FDA 510(k) clearance on 2016-06-28. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K160916.

When did CoRoent® Ti-C System receive FDA 510(k) clearance?

CoRoent® Ti-C System received FDA 510(k) clearance on 2016-06-28, under 510(k) number K160916.

Who is the listed applicant for CoRoent® Ti-C System?

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

What is the FDA product code for CoRoent® Ti-C System?

The FDA product code for CoRoent® Ti-C System is MAX.

其他以 Nu Vasive, Incorporated 為申請人之記錄

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K231735NuVasive CoRoent 小型間體系統；NuVasive CoRoent 小型曲面間體系統；NuVasive CoRoent 小型互鎖系統；NuVasive CoRoent 小型互鎖II系統；NuVasive CoRoent 小型Ti-C系統；NuVasive Cohere 頸椎間體系統 K230894NuVasive Modulus ALIF 系統 K230989醫療設備註冊框架 K223181NuVasive Reline 系統 K221751NuVasive Cohere ALIF 系統脊椎間融合設備 K221388NuVasive Reline 頸椎系統

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相關器械（代碼：MAX）

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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