NextAR TKA 平台
K号: K193559 · 2020-07-10
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决定日期2020-07-10
产品代码SBF
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
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器械摘要
NextAR TKA Platform is the device name listed in this FDA 510(k) record. The listed applicant is Medacta Inernational SA. It received FDA 510(k) clearance on 2020-07-10 under 510(k) number K193559. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the NextAR TKA Platform?
NextAR TKA Platform is a medical device that received FDA 510(k) clearance on 2020-07-10. The listed applicant is Medacta Inernational SA. The 510(k) number is K193559.
When did NextAR TKA Platform receive FDA 510(k) clearance?
NextAR TKA Platform received FDA 510(k) clearance on 2020-07-10, under 510(k) number K193559.
Who is the listed applicant for NextAR TKA Platform?
The FDA 510(k) record lists Medacta Inernational SA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NextAR TKA Platform?
The FDA product code for NextAR TKA Platform is SBF.
相关临床试验
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列明Medacta Inernational SA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：SBF）
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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