FDA 510(k)

ROSA ONE脊椎應用

K 號：K182848 · 2019-03-22

決定日期2019-03-22

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

ROSA ONE Spine application is the device name listed in this FDA 510(k) record. The listed applicant is Medtech S.A. It received FDA 510(k) clearance on 2019-03-22 under 510(k) number K182848. 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 ROSA ONE Spine application?

ROSA ONE Spine application is a medical device that received FDA 510(k) clearance on 2019-03-22. The listed applicant is Medtech S.A. The 510(k) number is K182848.

When did ROSA ONE Spine application receive FDA 510(k) clearance?

ROSA ONE Spine application received FDA 510(k) clearance on 2019-03-22, under 510(k) number K182848.

Who is the listed applicant for ROSA ONE Spine application?

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

What is the FDA product code for ROSA ONE Spine application?

The FDA product code for ROSA ONE Spine application is OLO.

其他以 Medtech S.A 為申請人之記錄

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相關器械（代碼：OLO）

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官方來源

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