FDA 510(k)

Gibralt®脊椎系統及Gibralt®顳骨脊椎系統

K 號：K160697 · 2016-06-28

決定日期2016-06-28

產品代碼NKG

諮詢委員會或

決定相當於

器材摘要

Gibralt® Spine System and Gibralt® Occipital Spine System is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2016-06-28 under 510(k) number K160697. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Gibralt® Spine System and Gibralt® Occipital Spine System?

Gibralt® Spine System and Gibralt® Occipital Spine System is a medical device that received FDA 510(k) clearance on 2016-06-28. The listed applicant is Exactech, Inc.. The 510(k) number is K160697.

When did Gibralt® Spine System and Gibralt® Occipital Spine System receive FDA 510(k) clearance?

Gibralt® Spine System and Gibralt® Occipital Spine System received FDA 510(k) clearance on 2016-06-28, under 510(k) number K160697.

Who is the listed applicant for Gibralt® Spine System and Gibralt® Occipital Spine System?

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

What is the FDA product code for Gibralt® Spine System and Gibralt® Occipital Spine System?

The FDA product code for Gibralt® Spine System and Gibralt® Occipital Spine System is NKG.

其他以 Exactech, Inc. 為申請人之記錄

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相關器械（代碼：NKG）

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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