FDA 510(k)

Matira™ 頸部前方系統

K 號：K172086 · 2017-09-22

決定日期2017-09-22

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

Matira™ Anterior Cervical System is the device name listed in this FDA 510(k) record. The listed applicant is Kalitec Direct, LLC. It received FDA 510(k) clearance on 2017-09-22 under 510(k) number K172086. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Matira™ Anterior Cervical System?

Matira™ Anterior Cervical System is a medical device that received FDA 510(k) clearance on 2017-09-22. The listed applicant is Kalitec Direct, LLC. The 510(k) number is K172086.

When did Matira™ Anterior Cervical System receive FDA 510(k) clearance?

Matira™ Anterior Cervical System received FDA 510(k) clearance on 2017-09-22, under 510(k) number K172086.

Who is the listed applicant for Matira™ Anterior Cervical System?

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

What is the FDA product code for Matira™ Anterior Cervical System?

The FDA product code for Matira™ Anterior Cervical System is KWQ.

其他以 Kalitec Direct, LLC 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：KWQ）

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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