REGEN生物活性水泥
K号: K253337 · 2026-04-15
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决定日期2026-04-15
产品代码EMA
咨询委员会DE
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决定实质等同
器械摘要
REGEN Bioactive Cement is the device name listed in this FDA 510(k) record. The listed applicant is Inter-Med, Inc.. It received FDA 510(k) clearance on 2026-04-15 under 510(k) number K253337. 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 REGEN Bioactive Cement?
REGEN Bioactive Cement is a medical device that received FDA 510(k) clearance on 2026-04-15. The listed applicant is Inter-Med, Inc.. The 510(k) number is K253337.
When did REGEN Bioactive Cement receive FDA 510(k) clearance?
REGEN Bioactive Cement received FDA 510(k) clearance on 2026-04-15, under 510(k) number K253337.
Who is the listed applicant for REGEN Bioactive Cement?
The FDA 510(k) record lists Inter-Med, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for REGEN Bioactive Cement?
The FDA product code for REGEN Bioactive Cement is EMA.
相关临床试验
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列明Inter-Med, 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。
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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