椎板切除术器械，Kerrison 椎板切除术器械，IVD 椎板切除术器械
K号: K150468 · 2016-02-29
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决定日期2016-02-29
产品代码HAE
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
Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs is the device name listed in this FDA 510(k) record. The listed applicant is K2 Medical GmbH & Co. KG. It received FDA 510(k) clearance on 2016-02-29 under 510(k) number K150468. The device is classified under product code HAE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs?
Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs is a medical device that received FDA 510(k) clearance on 2016-02-29. The listed applicant is K2 Medical GmbH & Co. KG. The 510(k) number is K150468.
When did Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs receive FDA 510(k) clearance?
Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs received FDA 510(k) clearance on 2016-02-29, under 510(k) number K150468.
Who is the listed applicant for Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs?
The FDA 510(k) record lists K2 Medical GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs?
The FDA product code for Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs is HAE.
相关临床试验
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相关器械（代码：HAE）
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。
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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