Vertex 髋部骨折内固定系统
K号: K233910 · 2024-04-04
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申请人Orthoxel Dac
决定日期2024-04-04
产品代码HSB
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
Vertex Hip Fracture Nailing System is the device name listed in this FDA 510(k) record. The listed applicant is Orthoxel Dac. It received FDA 510(k) clearance on 2024-04-04 under 510(k) number K233910. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Vertex Hip Fracture Nailing System?
Vertex Hip Fracture Nailing System is a medical device that received FDA 510(k) clearance on 2024-04-04. The listed applicant is Orthoxel Dac. The 510(k) number is K233910.
When did Vertex Hip Fracture Nailing System receive FDA 510(k) clearance?
Vertex Hip Fracture Nailing System received FDA 510(k) clearance on 2024-04-04, under 510(k) number K233910.
Who is the listed applicant for Vertex Hip Fracture Nailing System?
The FDA 510(k) record lists Orthoxel Dac as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Vertex Hip Fracture Nailing System?
The FDA product code for Vertex Hip Fracture Nailing System is HSB.
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：HSB）
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。
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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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