X-BOLT 髋部骨折固定系统
K号: K181640 · 2018-10-12
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决定日期2018-10-12
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
X-BOLT Hip Fracture Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is X-Bolt Orthopaedics. It received FDA 510(k) clearance on 2018-10-12 under 510(k) number K181640. 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 X-BOLT Hip Fracture Fixation System?
X-BOLT Hip Fracture Fixation System is a medical device that received FDA 510(k) clearance on 2018-10-12. The listed applicant is X-Bolt Orthopaedics. The 510(k) number is K181640.
When did X-BOLT Hip Fracture Fixation System receive FDA 510(k) clearance?
X-BOLT Hip Fracture Fixation System received FDA 510(k) clearance on 2018-10-12, under 510(k) number K181640.
Who is the listed applicant for X-BOLT Hip Fracture Fixation System?
The FDA 510(k) record lists X-Bolt Orthopaedics as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for X-BOLT Hip Fracture Fixation System?
The FDA product code for X-BOLT Hip Fracture Fixation 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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