BioBrace® RC 递送系统
K号: K250395 · 2025-04-07
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决定日期2025-04-07
产品代码ORQ
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
BioBrace ® RC Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2025-04-07 under 510(k) number K250395. The device is classified under product code ORQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BioBrace ® RC Delivery System?
BioBrace ® RC Delivery System is a medical device that received FDA 510(k) clearance on 2025-04-07. The listed applicant is Conmed Corporation. The 510(k) number is K250395.
When did BioBrace ® RC Delivery System receive FDA 510(k) clearance?
BioBrace ® RC Delivery System received FDA 510(k) clearance on 2025-04-07, under 510(k) number K250395.
Who is the listed applicant for BioBrace ® RC Delivery System?
The FDA 510(k) record lists Conmed Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BioBrace ® RC Delivery System?
The FDA product code for BioBrace ® RC Delivery System is ORQ.
相关临床试验
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列明Conmed Corporation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。
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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