FDA 510(k)

胶原半月板植入物XL

K号: K170364 · 2017-05-02

决定日期2017-05-02

产品代码OLC

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决定实质等同

器械摘要

Collagen Meniscus Implant XL is the device name listed in this FDA 510(k) record. The listed applicant is Ivy Sports Medicine, LLC. It received FDA 510(k) clearance on 2017-05-02 under 510(k) number K170364. The device is classified under product code OLC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Collagen Meniscus Implant XL?

Collagen Meniscus Implant XL is a medical device that received FDA 510(k) clearance on 2017-05-02. The listed applicant is Ivy Sports Medicine, LLC. The 510(k) number is K170364.

When did Collagen Meniscus Implant XL receive FDA 510(k) clearance?

Collagen Meniscus Implant XL received FDA 510(k) clearance on 2017-05-02, under 510(k) number K170364.

Who is the listed applicant for Collagen Meniscus Implant XL?

The FDA 510(k) record lists Ivy Sports Medicine, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Collagen Meniscus Implant XL?

The FDA product code for Collagen Meniscus Implant XL is OLC.

列明Ivy Sports Medicine, LLC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。

K153087IvyAIR 半月板系统，弯曲型，IvyAIR 半月板系统，直型，IvyAIR 半月板系统，反向弯曲型

官方来源

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