RODIN水泥
K号: K251775 · 2025-09-02
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决定日期2025-09-02
产品代码EMA
咨询委员会DE
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器械摘要
RODIN Cement is the device name listed in this FDA 510(k) record. The listed applicant is Belport Company, Inc., Gingi-Pak. It received FDA 510(k) clearance on 2025-09-02 under 510(k) number K251775. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the RODIN Cement?
RODIN Cement is a medical device that received FDA 510(k) clearance on 2025-09-02. The listed applicant is Belport Company, Inc., Gingi-Pak. The 510(k) number is K251775.
When did RODIN Cement receive FDA 510(k) clearance?
RODIN Cement received FDA 510(k) clearance on 2025-09-02, under 510(k) number K251775.
Who is the listed applicant for RODIN Cement?
The FDA 510(k) record lists Belport Company, Inc., Gingi-Pak as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RODIN Cement?
The FDA product code for RODIN Cement is EMA.
相关临床试验
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列明Belport Company, Inc., Gingi-Pak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：EMA）
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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