FDA 510(k)

TranS1 間體融合系統

K 號：K191791 · 2019-09-25

申請人Trans1

決定日期2019-09-25

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

TranS1 Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Trans1. It received FDA 510(k) clearance on 2019-09-25 under 510(k) number K191791. 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 TranS1 Interbody Fusion System?

TranS1 Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2019-09-25. The listed applicant is Trans1. The 510(k) number is K191791.

When did TranS1 Interbody Fusion System receive FDA 510(k) clearance?

TranS1 Interbody Fusion System received FDA 510(k) clearance on 2019-09-25, under 510(k) number K191791.

Who is the listed applicant for TranS1 Interbody Fusion System?

The FDA 510(k) record lists Trans1 as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TranS1 Interbody Fusion System?

The FDA product code for TranS1 Interbody Fusion System is MAX.

其他以 Trans1 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。

K192792TranS1 AxiaLIF Plus 系統

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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官方來源

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