Rebuilder神经引导导管
K号: K230794 · 2024-01-29
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决定日期2024-01-29
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。
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器械摘要
Rebuilder Nerve Guidance Conduit is the device name listed in this FDA 510(k) record. The listed applicant is Celestray Biotech Company, LLC.,. It received FDA 510(k) clearance on 2024-01-29 under 510(k) number K230794. 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 Rebuilder Nerve Guidance Conduit?
Rebuilder Nerve Guidance Conduit is a medical device that received FDA 510(k) clearance on 2024-01-29. The listed applicant is Celestray Biotech Company, LLC.,. The 510(k) number is K230794.
When did Rebuilder Nerve Guidance Conduit receive FDA 510(k) clearance?
Rebuilder Nerve Guidance Conduit received FDA 510(k) clearance on 2024-01-29, under 510(k) number K230794.
Who is the listed applicant for Rebuilder Nerve Guidance Conduit?
The FDA 510(k) record lists Celestray Biotech Company, LLC., as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Rebuilder Nerve Guidance Conduit?
The FDA product code for Rebuilder Nerve Guidance Conduit 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Celestray Biotech Company, LLC.,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。
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