Aptis Medical Distal Radio Ulnar Joint Implant
K号: K190599 · 2019-05-03
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决定日期2019-05-03
产品代码KXE
咨询委员会OR
请注意，由于原文中未提供具体的医疗设备监管文本，以下是一个示例翻译，您可以根据实际文本进行调整：
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产品名称：[产品名称]
公司名称：[公司名称]
根据FDA 510(k)预市场批准程序，[产品名称]已获得批准，用于[产品用途描述]。
产品注册号：[注册号]
PMA编号：[PMA编号]
临床试验编号（NCT）：[NCT编号]
PubMed ID（PMID）：[PMID编号]
更多信息请访问以下链接：
[URL]
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请将上述示例中的[产品名称]、[公司名称]、[注册号]、[PMA编号]、[NCT编号]、[PMID编号]和[URL]替换为实际的文本内容。
决定实质等同
器械摘要
Aptis Medical Distal Radio Ulnar Joint Implant is the device name listed in this FDA 510(k) record. The listed applicant is Aptis Medical, LLC. It received FDA 510(k) clearance on 2019-05-03 under 510(k) number K190599. The device is classified under product code KXE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Aptis Medical Distal Radio Ulnar Joint Implant?
Aptis Medical Distal Radio Ulnar Joint Implant is a medical device that received FDA 510(k) clearance on 2019-05-03. The listed applicant is Aptis Medical, LLC. The 510(k) number is K190599.
When did Aptis Medical Distal Radio Ulnar Joint Implant receive FDA 510(k) clearance?
Aptis Medical Distal Radio Ulnar Joint Implant received FDA 510(k) clearance on 2019-05-03, under 510(k) number K190599.
Who is the listed applicant for Aptis Medical Distal Radio Ulnar Joint Implant?
The FDA 510(k) record lists Aptis Medical, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Aptis Medical Distal Radio Ulnar Joint Implant?
The FDA product code for Aptis Medical Distal Radio Ulnar Joint Implant is KXE.
相关临床试验
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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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