FDA 510(k)

脊椎波導航儀器

K 號：K181596 · 2018-10-24

決定日期2018-10-24

產品代碼OLO

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Spine Wave Navigated Instruments 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 2018-10-24 under 510(k) number K181596. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Spine Wave Navigated Instruments?

Spine Wave Navigated Instruments is a medical device that received FDA 510(k) clearance on 2018-10-24. The listed applicant is Spine Wave, Inc.. The 510(k) number is K181596.

When did Spine Wave Navigated Instruments receive FDA 510(k) clearance?

Spine Wave Navigated Instruments received FDA 510(k) clearance on 2018-10-24, under 510(k) number K181596.

Who is the listed applicant for Spine Wave Navigated Instruments?

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 Navigated Instruments?

The FDA product code for Spine Wave Navigated Instruments is OLO.

其他以 Spine Wave, Inc. 為申請人之記錄

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相關器械（代碼：OLO）

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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