XO1 膝关节平衡系统
K号: K162237 · 2017-04-25
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决定日期2017-04-25
产品代码ONN
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。
决定实质等同
器械摘要
XO1 Knee Balancing System is the device name listed in this FDA 510(k) record. The listed applicant is Xpandortho, Inc.. It received FDA 510(k) clearance on 2017-04-25 under 510(k) number K162237. The device is classified under product code ONN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the XO1 Knee Balancing System?
XO1 Knee Balancing System is a medical device that received FDA 510(k) clearance on 2017-04-25. The listed applicant is Xpandortho, Inc.. The 510(k) number is K162237.
When did XO1 Knee Balancing System receive FDA 510(k) clearance?
XO1 Knee Balancing System received FDA 510(k) clearance on 2017-04-25, under 510(k) number K162237.
Who is the listed applicant for XO1 Knee Balancing System?
The FDA 510(k) record lists Xpandortho, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for XO1 Knee Balancing System?
The FDA product code for XO1 Knee Balancing System is ONN.
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：ONN）
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
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