导航椎弓根进入套件
K号: K191012 · 2019-08-07
广告
决定日期2019-08-07
产品代码OLO
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
Navigated Pedicle Access Kit is the device name listed in this FDA 510(k) record. The listed applicant is Izi Medical Products, LLC. It received FDA 510(k) clearance on 2019-08-07 under 510(k) number K191012. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Navigated Pedicle Access Kit?
Navigated Pedicle Access Kit is a medical device that received FDA 510(k) clearance on 2019-08-07. The listed applicant is Izi Medical Products, LLC. The 510(k) number is K191012.
When did Navigated Pedicle Access Kit receive FDA 510(k) clearance?
Navigated Pedicle Access Kit received FDA 510(k) clearance on 2019-08-07, under 510(k) number K191012.
Who is the listed applicant for Navigated Pedicle Access Kit?
The FDA 510(k) record lists Izi Medical Products, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Navigated Pedicle Access Kit?
The FDA product code for Navigated Pedicle Access Kit is OLO.
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。
列明Izi Medical Products, LLC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：OLO）
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。
广告