FDA 510(k)

Gentrix 手术矩阵厚型；Gentrix 手术矩阵延长型

K号: K170763 · 2017-06-08

决定日期2017-06-08

产品代码FTM

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决定实质等同

器械摘要

Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend is the device name listed in this FDA 510(k) record. The listed applicant is Acell, Inc.. It received FDA 510(k) clearance on 2017-06-08 under 510(k) number K170763. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend?

Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend is a medical device that received FDA 510(k) clearance on 2017-06-08. The listed applicant is Acell, Inc.. The 510(k) number is K170763.

When did Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend receive FDA 510(k) clearance?

Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend received FDA 510(k) clearance on 2017-06-08, under 510(k) number K170763.

Who is the listed applicant for Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend?

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

What is the FDA product code for Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend?

The FDA product code for Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend is FTM.

列明Acell, 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。

K241706MicroMatrix® UBM Particulate K241724Cytal®伤口基质；Cytal®烧伤基质 K230980MicroMatrix® Flex K191734MatriStem UBM 心包补片 K192725Cytal伤口基质3层 K182259Gentrix 手术矩阵，Gentrix 手术矩阵膈肌

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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。