FDA 510(k)

TAPESTRY 生物整合植入物

K号: K201572 · 2020-10-19

决定日期2020-10-19

产品代码OWY

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决定实质等同

器械摘要

TAPESTRY Biointegrative Implant is the device name listed in this FDA 510(k) record. The listed applicant is Embody, Inc.. It received FDA 510(k) clearance on 2020-10-19 under 510(k) number K201572. The device is classified under product code OWY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TAPESTRY Biointegrative Implant?

TAPESTRY Biointegrative Implant is a medical device that received FDA 510(k) clearance on 2020-10-19. The listed applicant is Embody, Inc.. The 510(k) number is K201572.

When did TAPESTRY Biointegrative Implant receive FDA 510(k) clearance?

TAPESTRY Biointegrative Implant received FDA 510(k) clearance on 2020-10-19, under 510(k) number K201572.

Who is the listed applicant for TAPESTRY Biointegrative Implant?

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

What is the FDA product code for TAPESTRY Biointegrative Implant?

The FDA product code for TAPESTRY Biointegrative Implant is OWY.

列明Embody, 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。

K252647Tapestry 生物整合植入物 K223822ACTIVBRAID™K220867Tapestry 生物整合植入物 K213958可吸收锚 K212306Tapestry 生物整合植入物

官方来源

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