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FDA 510(k)

Innovasis 导航仪器（Vector G-E 导航仪器和Excella G-E 导航仪器）

K号: K251073 · 2025-07-23

申请人Innovasis, Inc.
决定日期2025-07-23
产品代码OLO
咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同

器械摘要

Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) is the device name listed in this FDA 510(k) record. The listed applicant is Innovasis, Inc.. It received FDA 510(k) clearance on 2025-07-23 under 510(k) number K251073. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)?

Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) is a medical device that received FDA 510(k) clearance on 2025-07-23. The listed applicant is Innovasis, Inc.. The 510(k) number is K251073.

When did Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) receive FDA 510(k) clearance?

Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) received FDA 510(k) clearance on 2025-07-23, under 510(k) number K251073.

Who is the listed applicant for Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)?

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

What is the FDA product code for Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)?

The FDA product code for Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) is OLO.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Innovasis, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K250182Innovasis 导航仪器K241276Vector™ 椎弓根螺钉系统K231899HAtetracell™-C 钛合金颈椎椎间融合系统K223511Excella导航仪器K223510Matrix HA 融合多孔颈椎IBF系统K220875HAcancellous PEEK-C 多孔HA PEEK 颈椎IBF 系统

查看所有 20 个设备 →

相关器械（代码：OLO）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262506Remex脊柱外科导航 - 通用工具Remex Medical Corp.K261410Navbit MARQ（PRD-001-SUP（仰卧注册套件），PRD-001-LAT（侧卧注册套件））Suite 201, National Innovation CentreK261205SPINEART 导航仪器系统Spineart SAK261024TMINI微型机器人系统THINK Surgical, Inc.K262121离子-L 导航仪器SurGenTec, LLCK261113Op.n™ 脊柱导航和机器人引导Ecential Robotics

官方来源

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