FDA 510(k)

Alpine 粘合式髋關節系統

K 號：K153216 · 2016-02-18

決定日期2016-02-18

產品代碼JDI

諮詢委員會或

決定相當於

器材摘要

Alpine Cemented Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corporation. It received FDA 510(k) clearance on 2016-02-18 under 510(k) number K153216. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Alpine Cemented Hip System?

Alpine Cemented Hip System is a medical device that received FDA 510(k) clearance on 2016-02-18. The listed applicant is Ortho Development Corporation. The 510(k) number is K153216.

When did Alpine Cemented Hip System receive FDA 510(k) clearance?

Alpine Cemented Hip System received FDA 510(k) clearance on 2016-02-18, under 510(k) number K153216.

Who is the listed applicant for Alpine Cemented Hip System?

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

What is the FDA product code for Alpine Cemented Hip System?

The FDA product code for Alpine Cemented Hip System is JDI.

其他以 Ortho Development Corporation 為申請人之記錄

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相關器械（代碼：JDI）

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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