FDA 510(k)

凱易全髋系統

K 號：K191826 · 2020-05-14

申請人Beijing Keyi Medical Device Technology Co., Ltd.

決定日期2020-05-14

產品代碼LPH

諮詢委員會或

決定相當於

器材摘要

KeYi Total Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Keyi Medical Device Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-05-14 under 510(k) number K191826. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the KeYi Total Hip System?

KeYi Total Hip System is a medical device that received FDA 510(k) clearance on 2020-05-14. The listed applicant is Beijing Keyi Medical Device Technology Co., Ltd.. The 510(k) number is K191826.

When did KeYi Total Hip System receive FDA 510(k) clearance?

KeYi Total Hip System received FDA 510(k) clearance on 2020-05-14, under 510(k) number K191826.

Who is the listed applicant for KeYi Total Hip System?

The FDA 510(k) record lists Beijing Keyi Medical Device Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KeYi Total Hip System?

The FDA product code for KeYi Total Hip System is LPH.

其他以 Beijing Keyi Medical Device Technology Co., Ltd. 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。

K230120凱易全膝系統 K190567凱易脊椎固定系統 K162380鎖定板系統

相關器械（代碼：LPH）

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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