FDA 510(k)

牛真皮胶原蛋白真皮基质

K号: K243071 · 2024-12-19

决定日期2024-12-19

产品代码KGN

决定实质等同

器械摘要

Bovine Dermis Collagen Dermal Matrix 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 2024-12-19 under 510(k) number K243071. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

常见问题

What is the Bovine Dermis Collagen Dermal Matrix?

Bovine Dermis Collagen Dermal Matrix is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is Collagen Matrix, Inc.. The 510(k) number is K243071.

When did Bovine Dermis Collagen Dermal Matrix receive FDA 510(k) clearance?

Bovine Dermis Collagen Dermal Matrix received FDA 510(k) clearance on 2024-12-19, under 510(k) number K243071.

Who is the listed applicant for Bovine Dermis Collagen Dermal Matrix?

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 Bovine Dermis Collagen Dermal Matrix?

The FDA product code for Bovine Dermis Collagen Dermal Matrix is KGN.

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。

K251191胶原Dura再生膜 - 修复 K242302RejuvaKnee® 胶原纤维软骨植入物 K233203软组织增强可吸收基质 K240424矿物胶原蛋白复合生物活性可塑模具骨移植基质 K231942矿物胶原蛋白复合生物活性可塑模具 K221735矿物胶原蛋白复合生物活性可塑模具

查看所有 16 个设备 →

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.

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