FDA 510(k)

定制颅面植入物（CCI），定制颅骨植入物（CSI）

K号: K182711 · 2019-05-21

决定日期2019-05-21

产品代码GWO

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

Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) is the device name listed in this FDA 510(k) record. The listed applicant is Kelyniam Global, Inc.. It received FDA 510(k) clearance on 2019-05-21 under 510(k) number K182711. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)?

Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) is a medical device that received FDA 510(k) clearance on 2019-05-21. The listed applicant is Kelyniam Global, Inc.. The 510(k) number is K182711.

When did Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) receive FDA 510(k) clearance?

Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) received FDA 510(k) clearance on 2019-05-21, under 510(k) number K182711.

Who is the listed applicant for Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)?

The FDA 510(k) record lists Kelyniam Global, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)?

The FDA product code for Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) is GWO.

列明Kelyniam Global, 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。

K250334Fusion Craniofacial Implant; Fusion Skull Implant

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。