FDA 510(k)

Ax 独立 ALIF 系统

K号: K162236 · 2017-04-20

决定日期2017-04-20

产品代码OVD

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决定实质等同

器械摘要

Ax Stand-Alone ALIF System is the device name listed in this FDA 510(k) record. The listed applicant is Innovasis, Inc.. It received FDA 510(k) clearance on 2017-04-20 under 510(k) number K162236. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ax Stand-Alone ALIF System?

Ax Stand-Alone ALIF System is a medical device that received FDA 510(k) clearance on 2017-04-20. The listed applicant is Innovasis, Inc.. The 510(k) number is K162236.

When did Ax Stand-Alone ALIF System receive FDA 510(k) clearance?

Ax Stand-Alone ALIF System received FDA 510(k) clearance on 2017-04-20, under 510(k) number K162236.

Who is the listed applicant for Ax Stand-Alone ALIF System?

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

What is the FDA product code for Ax Stand-Alone ALIF System?

The FDA product code for Ax Stand-Alone ALIF System is OVD.

列明Innovasis, 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。

K251073Innovasis 导航仪器（Vector G-E 导航仪器和Excella G-E 导航仪器）K250182Innovasis 导航仪器 K241276Vector™ 椎弓根螺钉系统 K231899HAtetracell™-C 钛合金颈椎椎间融合系统 K223511Excella导航仪器 K223510Matrix HA 融合多孔颈椎IBF系统

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官方来源

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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。