FDA 510(k)

FasTouch可吸收固定系统

K号: K181668 · 2019-03-13

决定日期2019-03-13

产品代码GDW

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决定实质等同

器械摘要

FasTouch Absorbable Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Via Surgical , Ltd.. It received FDA 510(k) clearance on 2019-03-13 under 510(k) number K181668. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FasTouch Absorbable Fixation System?

FasTouch Absorbable Fixation System is a medical device that received FDA 510(k) clearance on 2019-03-13. The listed applicant is Via Surgical , Ltd.. The 510(k) number is K181668.

When did FasTouch Absorbable Fixation System receive FDA 510(k) clearance?

FasTouch Absorbable Fixation System received FDA 510(k) clearance on 2019-03-13, under 510(k) number K181668.

Who is the listed applicant for FasTouch Absorbable Fixation System?

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

What is the FDA product code for FasTouch Absorbable Fixation System?

The FDA product code for FasTouch Absorbable Fixation System is GDW.

列明Via Surgical , 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。

K203117组织贴设备 K162252FasTouch固定系统

相关器械（代码：GDW）

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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