FDA 510(k)

Optimus Neuro 系统

K号: K183352 · 2019-01-02

决定日期2019-01-02

产品代码GWO

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决定实质等同

器械摘要

Optimus Neuro System is the device name listed in this FDA 510(k) record. The listed applicant is Osteonic Co., Ltd.. It received FDA 510(k) clearance on 2019-01-02 under 510(k) number K183352. 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 Optimus Neuro System?

Optimus Neuro System is a medical device that received FDA 510(k) clearance on 2019-01-02. The listed applicant is Osteonic Co., Ltd.. The 510(k) number is K183352.

When did Optimus Neuro System receive FDA 510(k) clearance?

Optimus Neuro System received FDA 510(k) clearance on 2019-01-02, under 510(k) number K183352.

Who is the listed applicant for Optimus Neuro System?

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

What is the FDA product code for Optimus Neuro System?

The FDA product code for Optimus Neuro System is GWO.

列明Osteonic Co., Ltd.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。

K254182Aster K243469SIGNEX K243470Fix2Lock（PEEK 自打孔）K243467Fix2Lock（生物复合材料内侧，生物复合材料外侧，生物复合材料自打孔）K230546SIGNEX K233659缝合翼

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