FDA 510(k)

TELEX K 間體系統

K 號：K170890 · 2017-06-02

決定日期2017-06-02

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

TELIX K Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Biedermann Motech GmbH & Co. KG. It received FDA 510(k) clearance on 2017-06-02 under 510(k) number K170890. 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 TELIX K Interbody System?

TELIX K Interbody System is a medical device that received FDA 510(k) clearance on 2017-06-02. The listed applicant is Biedermann Motech GmbH & Co. KG. The 510(k) number is K170890.

When did TELIX K Interbody System receive FDA 510(k) clearance?

TELIX K Interbody System received FDA 510(k) clearance on 2017-06-02, under 510(k) number K170890.

Who is the listed applicant for TELIX K Interbody System?

The FDA 510(k) record lists Biedermann Motech GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TELIX K Interbody System?

The FDA product code for TELIX K Interbody System is MAX.

其他以 Biedermann Motech GmbH & Co. KG 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：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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