FDA 510(k)

TriALTIS 選向啟用儀器

K 號：K231527 · 2023-09-29

決定日期2023-09-29

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

TriALTIS Navigation Enabled Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Medos International Sàrl. It received FDA 510(k) clearance on 2023-09-29 under 510(k) number K231527. 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 TriALTIS Navigation Enabled Instruments?

TriALTIS Navigation Enabled Instruments is a medical device that received FDA 510(k) clearance on 2023-09-29. The listed applicant is Medos International Sàrl. The 510(k) number is K231527.

When did TriALTIS Navigation Enabled Instruments receive FDA 510(k) clearance?

TriALTIS Navigation Enabled Instruments received FDA 510(k) clearance on 2023-09-29, under 510(k) number K231527.

Who is the listed applicant for TriALTIS Navigation Enabled Instruments?

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

What is the FDA product code for TriALTIS Navigation Enabled Instruments?

The FDA product code for TriALTIS Navigation Enabled Instruments is OLO.

其他以 Medos International Sàrl 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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