FDA 510(k)

醫療設備註冊框架

K 號：K230989 · 2023-05-05

決定日期2023-05-05

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

Rod Registration Frame is the device name listed in this FDA 510(k) record. The listed applicant is Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2023-05-05 under 510(k) number K230989. 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 Rod Registration Frame?

Rod Registration Frame is a medical device that received FDA 510(k) clearance on 2023-05-05. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K230989.

When did Rod Registration Frame receive FDA 510(k) clearance?

Rod Registration Frame received FDA 510(k) clearance on 2023-05-05, under 510(k) number K230989.

Who is the listed applicant for Rod Registration Frame?

The FDA 510(k) record lists Nu Vasive, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rod Registration Frame?

The FDA product code for Rod Registration Frame is OLO.

其他以 Nu Vasive, Incorporated 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。

K231735NuVasive CoRoent 小型間體系統；NuVasive CoRoent 小型曲面間體系統；NuVasive CoRoent 小型互鎖系統；NuVasive CoRoent 小型互鎖II系統；NuVasive CoRoent 小型Ti-C系統；NuVasive Cohere 頸椎間體系統 K230894NuVasive Modulus ALIF 系統 K223181NuVasive Reline 系統 K221751NuVasive Cohere ALIF 系統脊椎間融合設備 K221388NuVasive Reline 頸椎系統 K220478NuVasive MOD-EX XLIF 間置系統，NuVasive MOD-EX XLIF 鋼板 2.0 間置系統

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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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