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FDA 510(k)

Anatase 腰椎手術導航系統及 Remex 腰椎手術導航系統 II

K 號：K251315 · 2025-05-29

申請人Remex Medical Corp.
決定日期2025-05-29
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

Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II is the device name listed in this FDA 510(k) record. The listed applicant is Remex Medical Corp.. It received FDA 510(k) clearance on 2025-05-29 under 510(k) number K251315. 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 Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II?

Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II is a medical device that received FDA 510(k) clearance on 2025-05-29. The listed applicant is Remex Medical Corp.. The 510(k) number is K251315.

When did Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II receive FDA 510(k) clearance?

Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II received FDA 510(k) clearance on 2025-05-29, under 510(k) number K251315.

Who is the listed applicant for Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II?

FDA 510(k) 記錄將 Remex Medical Corp. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II?

The FDA product code for Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II 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 Remex Medical Corp. 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。

K262506Remex脊椎手術導航 - 適用儀器K243560Remex脊椎手術導航儀K241625Anatase Navi 可用式儀器K233513Remex脊椎手術導航系統IIK230783Anatase 腰椎手術導航系統

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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