FDA 510(k)

K2M 閃爍釘系統

K 號：K152872 · 2016-01-05

申請人K2m

決定日期2016-01-05

產品代碼KNW

諮詢委員會GU

決定相當於

器材摘要

K2M Fenestrated Tap System is the device name listed in this FDA 510(k) record. The listed applicant is K2m. It received FDA 510(k) clearance on 2016-01-05 under 510(k) number K152872. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the K2M Fenestrated Tap System?

K2M Fenestrated Tap System is a medical device that received FDA 510(k) clearance on 2016-01-05. The listed applicant is K2m. The 510(k) number is K152872.

When did K2M Fenestrated Tap System receive FDA 510(k) clearance?

K2M Fenestrated Tap System received FDA 510(k) clearance on 2016-01-05, under 510(k) number K152872.

Who is the listed applicant for K2M Fenestrated Tap System?

The FDA 510(k) record lists K2m as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K2M Fenestrated Tap System?

The FDA product code for K2M Fenestrated Tap System is KNW.

其他以 K2m 為申請人之記錄

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相關器械（代碼：KNW）

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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