FDA 510(k)

Arrowhead Mini-Rail 固定器

K 號：K162032 · 2017-02-21

決定日期2017-02-21

產品代碼KTT

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決定相當於

器材摘要

Arrowhead Mini-Rail Fixator is the device name listed in this FDA 510(k) record. The listed applicant is Arrowhead De, LLC. It received FDA 510(k) clearance on 2017-02-21 under 510(k) number K162032. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Arrowhead Mini-Rail Fixator?

Arrowhead Mini-Rail Fixator is a medical device that received FDA 510(k) clearance on 2017-02-21. The listed applicant is Arrowhead De, LLC. The 510(k) number is K162032.

When did Arrowhead Mini-Rail Fixator receive FDA 510(k) clearance?

Arrowhead Mini-Rail Fixator received FDA 510(k) clearance on 2017-02-21, under 510(k) number K162032.

Who is the listed applicant for Arrowhead Mini-Rail Fixator?

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

What is the FDA product code for Arrowhead Mini-Rail Fixator?

The FDA product code for Arrowhead Mini-Rail Fixator is KTT.

其他以 Arrowhead De, 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：KTT）

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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