T2
K号: K212303 · 2021-09-21
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器械摘要
T2 is the device name listed in this FDA 510(k) record. The listed applicant is Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2021-09-21 under 510(k) number K212303. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the T2?
T2 is a medical device that received FDA 510(k) clearance on 2021-09-21. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K212303.
When did T2 receive FDA 510(k) clearance?
T2 received FDA 510(k) clearance on 2021-09-21, under 510(k) number K212303.
Who is the listed applicant for T2?
The FDA 510(k) record lists Osstem Implant Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for T2?
The FDA product code for T2 is OAS.
列明Osstem Implant Co., Ltd.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:OAS)
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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