FDA 510(k)

iFuse植入系统- iFuse导航

K号: K172268 · 2017-10-31

决定日期2017-10-31

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

iFuse Implant System- iFuse Navigation is the device name listed in this FDA 510(k) record. The listed applicant is SI-BONE, Inc.. It received FDA 510(k) clearance on 2017-10-31 under 510(k) number K172268. 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 iFuse Implant System- iFuse Navigation?

iFuse Implant System- iFuse Navigation is a medical device that received FDA 510(k) clearance on 2017-10-31. The listed applicant is SI-BONE, Inc.. The 510(k) number is K172268.

When did iFuse Implant System- iFuse Navigation receive FDA 510(k) clearance?

iFuse Implant System- iFuse Navigation received FDA 510(k) clearance on 2017-10-31, under 510(k) number K172268.

Who is the listed applicant for iFuse Implant System- iFuse Navigation?

FDA 510(k)记录中列出SI-BONE，Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for iFuse Implant System- iFuse Navigation?

The FDA product code for iFuse Implant System- iFuse Navigation is OLO.

列明SI-BONE, Inc.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。

K262067iFuse Granite Onyx™植入系统 K253488iFuse INTRA Ti™植入系统 K253094iFuse Bedrock花岗岩植入系统 K251780iGPS 导航仪器 K241504iFuse TORQ TNT™植入系统 K241574iFuse TORQ®植入系统

查看所有 23 个设备 →

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。