BTI Interna 假体组件
K号: K232750 · 2023-12-08
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决定日期2023-12-08
产品代码NHA
咨询委员会DE
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决定实质等同
器械摘要
BTI Interna Prosthetic Components is the device name listed in this FDA 510(k) record. The listed applicant is B.T.I. Biotechnology Institute, Sl.. It received FDA 510(k) clearance on 2023-12-08 under 510(k) number K232750. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BTI Interna Prosthetic Components?
BTI Interna Prosthetic Components is a medical device that received FDA 510(k) clearance on 2023-12-08. The listed applicant is B.T.I. Biotechnology Institute, Sl.. The 510(k) number is K232750.
When did BTI Interna Prosthetic Components receive FDA 510(k) clearance?
BTI Interna Prosthetic Components received FDA 510(k) clearance on 2023-12-08, under 510(k) number K232750.
Who is the listed applicant for BTI Interna Prosthetic Components?
The FDA 510(k) record lists B.T.I. Biotechnology Institute, Sl. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BTI Interna Prosthetic Components?
The FDA product code for BTI Interna Prosthetic Components is NHA.
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。
列明B.T.I. Biotechnology Institute, Sl.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：NHA）
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。
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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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