FDA 510(k)

Ayers Rock 頸椎間融合系統

K 號：K162694 · 2017-01-12

決定日期2017-01-12

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

Ayers Rock Cervical interbody fusion system is the device name listed in this FDA 510(k) record. The listed applicant is Spineway. It received FDA 510(k) clearance on 2017-01-12 under 510(k) number K162694. 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 Ayers Rock Cervical interbody fusion system?

Ayers Rock Cervical interbody fusion system is a medical device that received FDA 510(k) clearance on 2017-01-12. The listed applicant is Spineway. The 510(k) number is K162694.

When did Ayers Rock Cervical interbody fusion system receive FDA 510(k) clearance?

Ayers Rock Cervical interbody fusion system received FDA 510(k) clearance on 2017-01-12, under 510(k) number K162694.

Who is the listed applicant for Ayers Rock Cervical interbody fusion system?

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

What is the FDA product code for Ayers Rock Cervical interbody fusion system?

The FDA product code for Ayers Rock Cervical interbody fusion system is ODP.

其他以 Spineway 為申請人之記錄

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K231658VEOS脊椎固定系統

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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