皮瓣固定器，骨孔盖
K号: K192310 · 2020-06-03
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决定日期2020-06-03
产品代码GXR
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
Flap Fixator, Burr Hole Cover is the device name listed in this FDA 510(k) record. The listed applicant is Ossaware Biotech Co., Ltd.. It received FDA 510(k) clearance on 2020-06-03 under 510(k) number K192310. 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 Flap Fixator, Burr Hole Cover?
Flap Fixator, Burr Hole Cover is a medical device that received FDA 510(k) clearance on 2020-06-03. The listed applicant is Ossaware Biotech Co., Ltd.. The 510(k) number is K192310.
When did Flap Fixator, Burr Hole Cover receive FDA 510(k) clearance?
Flap Fixator, Burr Hole Cover received FDA 510(k) clearance on 2020-06-03, under 510(k) number K192310.
Who is the listed applicant for Flap Fixator, Burr Hole Cover?
The FDA 510(k) record lists Ossaware Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Flap Fixator, Burr Hole Cover?
The FDA product code for Flap Fixator, Burr Hole 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。
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.K192162NeuroVention 颅骨固定系统，NuCrani 板，KTC 穿刺孔盖，DC 板Neurovention, LLCK181539OSSDSIGN CranioplugOssdsign ABK181382GuardianTM Burr Hole Cover SystemSt Jude Medical
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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