FDA 510(k)

Altus Spine 導航系統

K 號：K243419 · 2025-05-08

決定日期2025-05-08

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

Altus Spine Navigation System is the device name listed in this FDA 510(k) record. The listed applicant is Altus Partners, LLC. It received FDA 510(k) clearance on 2025-05-08 under 510(k) number K243419. 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 Altus Spine Navigation System?

Altus Spine Navigation System is a medical device that received FDA 510(k) clearance on 2025-05-08. The listed applicant is Altus Partners, LLC. The 510(k) number is K243419.

When did Altus Spine Navigation System receive FDA 510(k) clearance?

Altus Spine Navigation System received FDA 510(k) clearance on 2025-05-08, under 510(k) number K243419.

Who is the listed applicant for Altus Spine Navigation System?

The FDA 510(k) record lists Altus Partners, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Altus Spine Navigation System?

The FDA product code for Altus Spine Navigation System is OLO.

其他以 Altus Partners, LLC 為申請人之記錄

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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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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官方來源

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