FDA 510(k)

软组织增强可吸收基质

K号: K233203 · 2024-05-01

决定日期2024-05-01

产品代码NPL

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决定实质等同

器械摘要

Soft Tissue Augmentation Resorbable 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 2024-05-01 under 510(k) number K233203. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Soft Tissue Augmentation Resorbable Matrix?

Soft Tissue Augmentation Resorbable Matrix is a medical device that received FDA 510(k) clearance on 2024-05-01. The listed applicant is Collagen Matrix, Inc.. The 510(k) number is K233203.

When did Soft Tissue Augmentation Resorbable Matrix receive FDA 510(k) clearance?

Soft Tissue Augmentation Resorbable Matrix received FDA 510(k) clearance on 2024-05-01, under 510(k) number K233203.

Who is the listed applicant for Soft Tissue Augmentation Resorbable 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 Soft Tissue Augmentation Resorbable Matrix?

The FDA product code for Soft Tissue Augmentation Resorbable Matrix is NPL.

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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相关器械（代码：NPL）

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。

K242817Jason 膜Botiss Biomaterials GmbH K250512增强牙龈基质Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.K252253Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®Geistlich Pharma AG K251062Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi PackGeistlich Pharma AG K250833SwissMembrane X；SwissMembrane X 插座Geistlich Pharma AG K231513口腔基质Beijing Biosis Healing Biolog Ical Technology Co., Ltd.

官方来源

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