FDA 510(k)

AOS 前外侧近端肱骨板

K 號：K171606 · 2017-06-22

申請人Advanced Orthopaedic Solutions, Inc. (Aos)

決定日期2017-06-22

產品代碼KTW

諮詢委員會或

決定相當於

器材摘要

AOS Anterolateral Proximal Humeral Plate is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Orthopaedic Solutions, Inc. (Aos). It received FDA 510(k) clearance on 2017-06-22 under 510(k) number K171606. The device is classified under product code KTW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AOS Anterolateral Proximal Humeral Plate?

AOS Anterolateral Proximal Humeral Plate is a medical device that received FDA 510(k) clearance on 2017-06-22. The listed applicant is Advanced Orthopaedic Solutions, Inc. (Aos). The 510(k) number is K171606.

When did AOS Anterolateral Proximal Humeral Plate receive FDA 510(k) clearance?

AOS Anterolateral Proximal Humeral Plate received FDA 510(k) clearance on 2017-06-22, under 510(k) number K171606.

Who is the listed applicant for AOS Anterolateral Proximal Humeral Plate?

The FDA 510(k) record lists Advanced Orthopaedic Solutions, Inc. (Aos) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AOS Anterolateral Proximal Humeral Plate?

The FDA product code for AOS Anterolateral Proximal Humeral Plate is KTW.

其他以 Advanced Orthopaedic Solutions, Inc. (Aos) 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：KTW）

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。

K182285PK 高胫骨截骨校正系統Paonan Biotech Co., Ltd.K170693幻影小型骨內髓釘系統Paragon 28, Inc.K160409AOS 前外侧近端肱骨板Advanced Orthopaedic Solutions, Inc.

官方來源

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