FDA 510(k)

脊椎波前頸椎系統

K 號：K162760 · 2017-02-16

決定日期2017-02-16

產品代碼OVE

諮詢委員會或

決定相當於

器材摘要

Spine Wave Anterior Cervical Spine System is the device name listed in this FDA 510(k) record. The listed applicant is Spine Wave, Inc.. It received FDA 510(k) clearance on 2017-02-16 under 510(k) number K162760. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Spine Wave Anterior Cervical Spine System?

Spine Wave Anterior Cervical Spine System is a medical device that received FDA 510(k) clearance on 2017-02-16. The listed applicant is Spine Wave, Inc.. The 510(k) number is K162760.

When did Spine Wave Anterior Cervical Spine System receive FDA 510(k) clearance?

Spine Wave Anterior Cervical Spine System received FDA 510(k) clearance on 2017-02-16, under 510(k) number K162760.

Who is the listed applicant for Spine Wave Anterior Cervical Spine System?

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

What is the FDA product code for Spine Wave Anterior Cervical Spine System?

The FDA product code for Spine Wave Anterior Cervical Spine System is OVE.

其他以 Spine Wave, Inc. 為申請人之記錄

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相關器械（代碼：OVE）

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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