FDA 510(k)

Axis Chena 頸椎 PEEK Spacer 系統

K 號：K181140 · 2018-11-16

決定日期2018-11-16

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

Axis Chena Cervical PEEK Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Axis Orthopaedics. It received FDA 510(k) clearance on 2018-11-16 under 510(k) number K181140. 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 Axis Chena Cervical PEEK Spacer System?

Axis Chena Cervical PEEK Spacer System is a medical device that received FDA 510(k) clearance on 2018-11-16. The listed applicant is Axis Orthopaedics. The 510(k) number is K181140.

When did Axis Chena Cervical PEEK Spacer System receive FDA 510(k) clearance?

Axis Chena Cervical PEEK Spacer System received FDA 510(k) clearance on 2018-11-16, under 510(k) number K181140.

Who is the listed applicant for Axis Chena Cervical PEEK Spacer System?

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

What is the FDA product code for Axis Chena Cervical PEEK Spacer System?

The FDA product code for Axis Chena Cervical PEEK Spacer System is ODP.

其他以 Axis Orthopaedics 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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