FDA 510(k)

無敵機器人導航儀器

K 號：K232044 · 2023-10-06

決定日期2023-10-06

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

Invictus Robotic Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K232044. 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 Invictus Robotic Navigation Instruments?

Invictus Robotic Navigation Instruments is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K232044.

When did Invictus Robotic Navigation Instruments receive FDA 510(k) clearance?

Invictus Robotic Navigation Instruments received FDA 510(k) clearance on 2023-10-06, under 510(k) number K232044.

Who is the listed applicant for Invictus Robotic Navigation Instruments?

FDA 510(k) 記錄將 Alphatec Spine, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Invictus Robotic Navigation Instruments?

The FDA product code for Invictus Robotic Navigation Instruments is OLO.

其他以 Alphatec Spine, 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。

K261284Invictus® 小身材脊椎固定系統；Invictus® 2.0 脊椎固定系統 K253216內科手術對齊系統；CONTOUR3D 弯曲系統 K253615無敵帶系統 K252597Valence機器人導航系統；Valence機器人導航儀器（與StealthStation共用）K252842SafeOp 3：神經資訊系統 K251965近端前頸板系統；節段性板金系統（SPS）

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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。

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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