FDA 510(k)

NovoGen 创面基质

K号: K220498 · 2023-06-09

决定日期2023-06-09

产品代码KGN

决定实质等同

器械摘要

NovoGen Wound Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Novabone Products, LLC. It received FDA 510(k) clearance on 2023-06-09 under 510(k) number K220498. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常见问题

What is the NovoGen Wound Matrix?

NovoGen Wound Matrix is a medical device that received FDA 510(k) clearance on 2023-06-09. The listed applicant is Novabone Products, LLC. The 510(k) number is K220498.

When did NovoGen Wound Matrix receive FDA 510(k) clearance?

NovoGen Wound Matrix received FDA 510(k) clearance on 2023-06-09, under 510(k) number K220498.

Who is the listed applicant for NovoGen Wound Matrix?

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

What is the FDA product code for NovoGen Wound Matrix?

The FDA product code for NovoGen Wound Matrix is KGN.

列明Novabone Products, 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。

K242299NovaBone Putty - 合成生物活性骨移植 K240404NovaBone Putty - 生物活性合成骨移植（NB6600，NB6610，NB6615）K163310NovaBone IRM

相关器械（代码：KGN）

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。

K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus 手术基质，1cc（CG-01AP）；Accelagen Plus 手术基质，3cc（CG-03AP）；Accelagen Plus 手术基质，5cc（CG-05AP）；Accelagen Plus 手术条带，125x25x2mm（CG-125X25AP）；Accelagen Plus 手术条带，250x25x2mm（CG-250X25AP）Berkeley Advanced Biomaterials K260596胶原蛋白伤口粉Ventris Medical K260669Endoform 皮肤模板Aroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。