ATOZ 微型螺丝
K号: K210559 · 2021-12-19
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决定日期2021-12-19
产品代码OAT
咨询委员会DE
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决定实质等同
器械摘要
ATOZ Mini-Screw is the device name listed in this FDA 510(k) record. The listed applicant is Mk Meditech, Inc.. It received FDA 510(k) clearance on 2021-12-19 under 510(k) number K210559. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ATOZ Mini-Screw?
ATOZ Mini-Screw is a medical device that received FDA 510(k) clearance on 2021-12-19. The listed applicant is Mk Meditech, Inc.. The 510(k) number is K210559.
When did ATOZ Mini-Screw receive FDA 510(k) clearance?
ATOZ Mini-Screw received FDA 510(k) clearance on 2021-12-19, under 510(k) number K210559.
Who is the listed applicant for ATOZ Mini-Screw?
The FDA 510(k) record lists Mk Meditech, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ATOZ Mini-Screw?
The FDA product code for ATOZ Mini-Screw is OAT.
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：OAT）
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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