FDA 510(k)

Integrity Implant

K号: K223538 · 2023-08-17

决定日期2023-08-17

产品代码OWX

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决定实质等同

器械摘要

Integrity Implant is the device name listed in this FDA 510(k) record. The listed applicant is Anika Therapeutics, Inc.. It received FDA 510(k) clearance on 2023-08-17 under 510(k) number K223538. The device is classified under product code OWX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Integrity Implant?

Integrity Implant is a medical device that received FDA 510(k) clearance on 2023-08-17. The listed applicant is Anika Therapeutics, Inc.. The 510(k) number is K223538.

When did Integrity Implant receive FDA 510(k) clearance?

Integrity Implant received FDA 510(k) clearance on 2023-08-17, under 510(k) number K223538.

Who is the listed applicant for Integrity Implant?

FDA 510(k)记录中列出Anika Therapeutics, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Integrity Implant?

The FDA product code for Integrity Implant is OWX.

列明Anika Therapeutics, 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。

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官方来源

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