FDA 510(k)

加固柔性胶原神经袖

K号: K170656 · 2017-06-01

决定日期2017-06-01

产品代码JXI

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决定实质等同

器械摘要

Reinforced Flexible Collagen Nerve Cuff 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 2017-06-01 under 510(k) number K170656. The device is classified under product code JXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Reinforced Flexible Collagen Nerve Cuff?

Reinforced Flexible Collagen Nerve Cuff is a medical device that received FDA 510(k) clearance on 2017-06-01. The listed applicant is Collagen Matrix, Inc.. The 510(k) number is K170656.

When did Reinforced Flexible Collagen Nerve Cuff receive FDA 510(k) clearance?

Reinforced Flexible Collagen Nerve Cuff received FDA 510(k) clearance on 2017-06-01, under 510(k) number K170656.

Who is the listed applicant for Reinforced Flexible Collagen Nerve Cuff?

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 Reinforced Flexible Collagen Nerve Cuff?

The FDA product code for Reinforced Flexible Collagen Nerve Cuff is JXI.

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：JXI）

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。

K260245SILKBridgeKLISBio S.r.l.K253363NeuroSpan 桥Auxilium Biotechnologies, Inc.K251505VersaCoat 神经保护器（VTP-44G2）；VersaCoat 神经保护器（VTP-12G1）Alafair Biosciences K251175VersaWrap 神经保护器（VTP-2201）；VersaWrap 神经保护器（VTP-1201）Alafair Biosciences K243889Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)Orthocell, Ltd.K242113神经缠绕（07-DW-001-TAB）Biocircuit Technologies, Inc.

官方来源

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