FDA 510(k)

斷髓術導航準備用儀器和通用導航适配器組

K 號：K212756 · 2022-05-05

決定日期2022-05-05

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

Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2022-05-05 under 510(k) number K212756. 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 Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set?

Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set is a medical device that received FDA 510(k) clearance on 2022-05-05. The listed applicant is Medos International SARL. The 510(k) number is K212756.

When did Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set receive FDA 510(k) clearance?

Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set received FDA 510(k) clearance on 2022-05-05, under 510(k) number K212756.

Who is the listed applicant for Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set?

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

What is the FDA product code for Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set?

The FDA product code for Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set is OLO.

其他以 Medos International SARL 為申請人之記錄

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相關器械（代碼：OLO）

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