FDA 510(k)

Cerafix Dura Substitute

K号: K153613 · 2016-03-16

决定日期2016-03-16

产品代码GXQ

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决定实质等同

器械摘要

Cerafix Dura Substitute is the device name listed in this FDA 510(k) record. The listed applicant is Acera Surgical, Inc.. It received FDA 510(k) clearance on 2016-03-16 under 510(k) number K153613. The device is classified under product code GXQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cerafix Dura Substitute?

Cerafix Dura Substitute is a medical device that received FDA 510(k) clearance on 2016-03-16. The listed applicant is Acera Surgical, Inc.. The 510(k) number is K153613.

When did Cerafix Dura Substitute receive FDA 510(k) clearance?

Cerafix Dura Substitute received FDA 510(k) clearance on 2016-03-16, under 510(k) number K153613.

Who is the listed applicant for Cerafix Dura Substitute?

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

What is the FDA product code for Cerafix Dura Substitute?

The FDA product code for Cerafix Dura Substitute is GXQ.

列明Acera Surgical, 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。

K251224Restrata 软组织加固（STR）K223725Restrata® MiniMatrix K193583Restrata®K172603Cerafix Dura Substitute K170300Restrata 创面基质 K161278Cerafix Dura Substitute

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