FDA 510(k)

Remex脊椎手術導航系統II

K 號：K233513 · 2024-05-01

決定日期2024-05-01

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

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 2024-05-01 under 510(k) number K233513. 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 Remex Spine Surgery Navigation System II?

Remex Spine Surgery Navigation System II is a medical device that received FDA 510(k) clearance on 2024-05-01. The listed applicant is Remex Medical Corp.. The 510(k) number is K233513.

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

Remex Spine Surgery Navigation System II received FDA 510(k) clearance on 2024-05-01, under 510(k) number K233513.

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

The FDA product code for Remex Spine Surgery Navigation System II is OLO.

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 K251315Anatase 腰椎手術導航系統及 Remex 腰椎手術導航系統 II K243560Remex脊椎手術導航儀 K241625Anatase Navi 可用式儀器 K230783Anatase 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 Centre K261205脊椎藝術導航儀器系統Spineart SA K261024TMINI 微型機器人系統THINK Surgical, Inc.K262121離子-L導航儀器SurGenTec, LLC K261113Op.n™脊椎導航與機械導引Ecential Robotics

官方來源

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