点植入系统
K号: K222738 · 2023-04-13
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决定日期2023-04-13
产品代码DZE
咨询委员会DE
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决定实质等同
器械摘要
Point implant system is the device name listed in this FDA 510(k) record. The listed applicant is Pointnix Co., Ltd.. It received FDA 510(k) clearance on 2023-04-13 under 510(k) number K222738. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Point implant system?
Point implant system is a medical device that received FDA 510(k) clearance on 2023-04-13. The listed applicant is Pointnix Co., Ltd.. The 510(k) number is K222738.
When did Point implant system receive FDA 510(k) clearance?
Point implant system received FDA 510(k) clearance on 2023-04-13, under 510(k) number K222738.
Who is the listed applicant for Point implant system?
The FDA 510(k) record lists Pointnix Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Point implant system?
The FDA product code for Point implant system is DZE.
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。
相关器械（代码：DZE）
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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