FDA 510(k)

TiGer Shark™ 系統

K 號：K172816 · 2018-01-26

決定日期2018-01-26

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

TiGer Shark™ System is the device name listed in this FDA 510(k) record. The listed applicant is Choicespine, LP. It received FDA 510(k) clearance on 2018-01-26 under 510(k) number K172816. 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 TiGer Shark™ System?

TiGer Shark™ System is a medical device that received FDA 510(k) clearance on 2018-01-26. The listed applicant is Choicespine, LP. The 510(k) number is K172816.

When did TiGer Shark™ System receive FDA 510(k) clearance?

TiGer Shark™ System received FDA 510(k) clearance on 2018-01-26, under 510(k) number K172816.

Who is the listed applicant for TiGer Shark™ System?

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

What is the FDA product code for TiGer Shark™ System?

The FDA product code for TiGer Shark™ System is MAX.

其他以 Choicespine, LP 為申請人之記錄

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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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