FDA 510(k)

SPINAUT-P

K号: K150915 · 2016-03-18

决定日期2016-03-18

产品代码GEI

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决定实质等同

器械摘要

SPINAUT-P is the device name listed in this FDA 510(k) record. The listed applicant is Imedicom Co., Ltd.. It received FDA 510(k) clearance on 2016-03-18 under 510(k) number K150915. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SPINAUT-P?

SPINAUT-P is a medical device that received FDA 510(k) clearance on 2016-03-18. The listed applicant is Imedicom Co., Ltd.. The 510(k) number is K150915.

When did SPINAUT-P receive FDA 510(k) clearance?

SPINAUT-P received FDA 510(k) clearance on 2016-03-18, under 510(k) number K150915.

Who is the listed applicant for SPINAUT-P?

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

What is the FDA product code for SPINAUT-P?

The FDA product code for SPINAUT-P is GEI.

列明Imedicom 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。

K182287MEDINAUT Plus K173541EPINAUT K153296MEDINAUT椎体成形术系统 K151268SPINAUT-V, SPINAUT-S, SPINAUT-I K150789SPINAUT-E, SPINAUT-I

相关器械（代码：GEI）

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。

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