AxoGuard 神经连接器
K号: K162741 · 2016-10-31
广告
决定日期2016-10-31
产品代码JXI
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
AxoGuard Nerve Connector is the device name listed in this FDA 510(k) record. The listed applicant is Cook Biotech Incorporated. It received FDA 510(k) clearance on 2016-10-31 under 510(k) number K162741. 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 AxoGuard Nerve Connector?
AxoGuard Nerve Connector is a medical device that received FDA 510(k) clearance on 2016-10-31. The listed applicant is Cook Biotech Incorporated. The 510(k) number is K162741.
When did AxoGuard Nerve Connector receive FDA 510(k) clearance?
AxoGuard Nerve Connector received FDA 510(k) clearance on 2016-10-31, under 510(k) number K162741.
Who is the listed applicant for AxoGuard Nerve Connector?
The FDA 510(k) record lists Cook Biotech Incorporated as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AxoGuard Nerve Connector?
The FDA product code for AxoGuard Nerve Connector is JXI.
相关临床试验
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。
列明Cook Biotech Incorporated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。
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 BiosciencesK251175VersaWrap 神经保护器（VTP-2201）；VersaWrap 神经保护器（VTP-1201）Alafair BiosciencesK242113神经缠绕（07-DW-001-TAB）Biocircuit Technologies, Inc.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.
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。
广告