FDA 510(k)

凱奧斯前方颈椎間融合設備系統

K 號：K212450 · 2022-06-06

申請人Keos

決定日期2022-06-06

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

Keos Anterior Cervical Interbody Fusion Device System is the device name listed in this FDA 510(k) record. The listed applicant is Keos. It received FDA 510(k) clearance on 2022-06-06 under 510(k) number K212450. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Keos Anterior Cervical Interbody Fusion Device System?

Keos Anterior Cervical Interbody Fusion Device System is a medical device that received FDA 510(k) clearance on 2022-06-06. The listed applicant is Keos. The 510(k) number is K212450.

When did Keos Anterior Cervical Interbody Fusion Device System receive FDA 510(k) clearance?

Keos Anterior Cervical Interbody Fusion Device System received FDA 510(k) clearance on 2022-06-06, under 510(k) number K212450.

Who is the listed applicant for Keos Anterior Cervical Interbody Fusion Device System?

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

What is the FDA product code for Keos Anterior Cervical Interbody Fusion Device System?

The FDA product code for Keos Anterior Cervical Interbody Fusion Device System is ODP.

其他以 Keos 為申請人之記錄

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相關器械（代碼：ODP）

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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