FDA 510(k)

aap LOQTEQ® 遠端桡骨板 2.7/3.5

K 號：K161696 · 2016-11-23

決定日期2016-11-23

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 is the device name listed in this FDA 510(k) record. The listed applicant is Aap Implantate AG. It received FDA 510(k) clearance on 2016-11-23 under 510(k) number K161696. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5?

aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 is a medical device that received FDA 510(k) clearance on 2016-11-23. The listed applicant is Aap Implantate AG. The 510(k) number is K161696.

When did aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 receive FDA 510(k) clearance?

aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 received FDA 510(k) clearance on 2016-11-23, under 510(k) number K161696.

Who is the listed applicant for aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5?

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

What is the FDA product code for aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5?

The FDA product code for aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 is HRS.

其他以 Aap Implantate AG 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：HRS）

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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