颅骨COVER
K号: K160739 · 2016-06-12
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决定日期2016-06-12
产品代码GXR
咨询委员会NE
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器械摘要
Cranial COVER is the device name listed in this FDA 510(k) record. The listed applicant is Neos Surgery S.L. It received FDA 510(k) clearance on 2016-06-12 under 510(k) number K160739. The device is classified under product code GXR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Cranial COVER?
Cranial COVER is a medical device that received FDA 510(k) clearance on 2016-06-12. The listed applicant is Neos Surgery S.L. The 510(k) number is K160739.
When did Cranial COVER receive FDA 510(k) clearance?
Cranial COVER received FDA 510(k) clearance on 2016-06-12, under 510(k) number K160739.
Who is the listed applicant for Cranial COVER?
The FDA 510(k) record lists Neos Surgery S.L as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Cranial COVER?
The FDA product code for Cranial COVER is GXR.
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Neos Surgery S.L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：GXR）
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。
K253447Montage 可流动设定，可吸收骨水泥（骨孔盖）Orthocon, Inc.K240137颅骨LOOP，颅骨LOOP L和颅骨LOOP XL颅骨固定系统Neos Surgery S.LK221606可吸收颅骨瓣固定系统Chendu Medart Medical Scientific Co., Ltd.K192310皮瓣固定器，骨孔盖Ossaware Biotech Co., Ltd.K192162NeuroVention 颅骨固定系统，NuCrani 板，KTC 穿刺孔盖，DC 板Neurovention, LLCK181539OSSDSIGN CranioplugOssdsign AB
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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