FDA 510(k)

CoreHip® 系統

K 號：K172235 · 2018-03-28

決定日期2018-03-28

產品代碼LZO

諮詢委員會或

決定相當於

器材摘要

CoreHip® System is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Implants Systems, LLC. It received FDA 510(k) clearance on 2018-03-28 under 510(k) number K172235. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CoreHip® System?

CoreHip® System is a medical device that received FDA 510(k) clearance on 2018-03-28. The listed applicant is Aesculap Implants Systems, LLC. The 510(k) number is K172235.

When did CoreHip® System receive FDA 510(k) clearance?

CoreHip® System received FDA 510(k) clearance on 2018-03-28, under 510(k) number K172235.

Who is the listed applicant for CoreHip® System?

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

What is the FDA product code for CoreHip® System?

The FDA product code for CoreHip® System is LZO.

其他以 Aesculap Implants Systems, LLC 為申請人之記錄

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K231769activL® 新一代儀器設備

相關器械（代碼：LZO）

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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