FDA 510(k)

凱易脊椎固定系統

K 號：K190567 · 2019-05-08

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

決定日期2019-05-08

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

KeYi Spinal Fixation 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 2019-05-08 under 510(k) number K190567. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the KeYi Spinal Fixation System?

KeYi Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2019-05-08. The listed applicant is Beijing Keyi Medical Device Technology Co., Ltd.. The 510(k) number is K190567.

When did KeYi Spinal Fixation System receive FDA 510(k) clearance?

KeYi Spinal Fixation System received FDA 510(k) clearance on 2019-05-08, under 510(k) number K190567.

Who is the listed applicant for KeYi Spinal Fixation 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 Spinal Fixation System?

The FDA product code for KeYi Spinal Fixation System is NKB.

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 K191826凱易全髋系統 K162380鎖定板系統

相關器械（代碼：NKB）

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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