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FDA 510(k)

Stealth AXiS™ 外科系統搭配 Stealth AXiS™ 脊椎臨床應用

K 號：K253381 · 2026-02-12

申請人Medtronic Navigation, Inc.
決定日期2026-02-12
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

Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application 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 2026-02-12 under 510(k) number K253381. 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 Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application?

Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application is a medical device that received FDA 510(k) clearance on 2026-02-12. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K253381.

When did Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application receive FDA 510(k) clearance?

Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application received FDA 510(k) clearance on 2026-02-12, under 510(k) number K253381.

Who is the listed applicant for Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application?

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 Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application?

The FDA product code for Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application is OLO.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Medtronic Navigation, Inc. 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。

K253379Stealth AXiS 頭部臨床應用K253395Stealth AXiS™ 鼻喉科臨床應用K253391視覺熱激光應用器系統 (9735559)；視覺熱激光應用器系統 (9735560)；視覺熱激光應用器系統 (9735561)K251282StealthStation S8 頸椎軟體K242464Stealth™脊椎夾具；ModuLeX™柄座安裝K240465O-arm O2影像系統

查看所有 24 項裝置 →

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。

K262506Remex脊椎手術導航 - 適用儀器Remex Medical Corp.K261410Navbit MARQ (PRD-001-SUP（仰臥登錄套件），PRD-001-LAT（側臥登錄套件）)Suite 201, National Innovation CentreK261205脊椎藝術導航儀器系統Spineart SAK261024TMINI 微型機器人系統THINK Surgical, Inc.K262121離子-L導航儀器SurGenTec, LLCK261113Op.n™脊椎導航與機械導引Ecential Robotics

官方來源

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