Spine 导航和机器人辅助设备
K号: K233228 · 2024-06-14
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决定日期2024-06-14
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
Spine Navigation and Robotic-Assistance Device is the device name listed in this FDA 510(k) record. The listed applicant is Ecential Robotics. It received FDA 510(k) clearance on 2024-06-14 under 510(k) number K233228. 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 Spine Navigation and Robotic-Assistance Device?
Spine Navigation and Robotic-Assistance Device is a medical device that received FDA 510(k) clearance on 2024-06-14. The listed applicant is Ecential Robotics. The 510(k) number is K233228.
When did Spine Navigation and Robotic-Assistance Device receive FDA 510(k) clearance?
Spine Navigation and Robotic-Assistance Device received FDA 510(k) clearance on 2024-06-14, under 510(k) number K233228.
Who is the listed applicant for Spine Navigation and Robotic-Assistance Device?
FDA 510(k)记录中列出Ecential Robotics为申请人。这本身并不足以确立该设备制造商的身份。
What is the FDA product code for Spine Navigation and Robotic-Assistance Device?
The FDA product code for Spine Navigation and Robotic-Assistance Device is OLO.
相关临床试验
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列明Ecential Robotics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。
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。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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