FDA 510(k)

VersaWrap 神经保护器

K号: K201631 · 2020-09-14

决定日期2020-09-14

产品代码JXI

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决定实质等同

器械摘要

VersaWrap Nerve Protector is the device name listed in this FDA 510(k) record. The listed applicant is Alafair Biosciences, Inc.. It received FDA 510(k) clearance on 2020-09-14 under 510(k) number K201631. 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 VersaWrap Nerve Protector?

VersaWrap Nerve Protector is a medical device that received FDA 510(k) clearance on 2020-09-14. The listed applicant is Alafair Biosciences, Inc.. The 510(k) number is K201631.

When did VersaWrap Nerve Protector receive FDA 510(k) clearance?

VersaWrap Nerve Protector received FDA 510(k) clearance on 2020-09-14, under 510(k) number K201631.

Who is the listed applicant for VersaWrap Nerve Protector?

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

What is the FDA product code for VersaWrap Nerve Protector?

The FDA product code for VersaWrap Nerve Protector is JXI.

列明Alafair Biosciences, 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。

K240817VersaWrap K232029VersaWrap 神经保护器 K213163VersaWrap K203600VersaWrap K200311VersaWrap 腱保护器 K160364VersaWrap 腱保护器

查看所有 7 个设备 →

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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