FDA 510(k)

StealthStation S8 頸椎軟體

K 號：K251282 · 2025-10-17

決定日期2025-10-17

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

StealthStation S8 Spine Software is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2025-10-17 under 510(k) number K251282. 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 StealthStation S8 Spine Software?

StealthStation S8 Spine Software is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K251282.

When did StealthStation S8 Spine Software receive FDA 510(k) clearance?

StealthStation S8 Spine Software received FDA 510(k) clearance on 2025-10-17, under 510(k) number K251282.

Who is the listed applicant for StealthStation S8 Spine Software?

The FDA 510(k) record lists Medtronic Navigation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for StealthStation S8 Spine Software?

The FDA product code for StealthStation S8 Spine Software is OLO.

其他以 Medtronic Navigation, 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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官方來源

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