FDA 510(k)

RejuvaKnee® 胶原纤维软骨植入物

K号: K242302 · 2024-10-02

决定日期2024-10-02

产品代码OLC

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决定实质等同

器械摘要

RejuvaKnee™ Collagen Meniscus Implant is the device name listed in this FDA 510(k) record. The listed applicant is Collagen Matrix, Inc.. It received FDA 510(k) clearance on 2024-10-02 under 510(k) number K242302. 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 RejuvaKnee™ Collagen Meniscus Implant?

RejuvaKnee™ Collagen Meniscus Implant is a medical device that received FDA 510(k) clearance on 2024-10-02. The listed applicant is Collagen Matrix, Inc.. The 510(k) number is K242302.

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

RejuvaKnee™ Collagen Meniscus Implant received FDA 510(k) clearance on 2024-10-02, under 510(k) number K242302.

Who is the listed applicant for RejuvaKnee™ Collagen Meniscus Implant?

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

What is the FDA product code for RejuvaKnee™ Collagen Meniscus Implant?

The FDA product code for RejuvaKnee™ Collagen Meniscus Implant is OLC.

列明Collagen Matrix, 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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