Alpine 钉合髋关节系统
K号: K153216 · 2016-02-18
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决定日期2016-02-18
产品代码JDI
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
Alpine Cemented Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corporation. It received FDA 510(k) clearance on 2016-02-18 under 510(k) number K153216. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Alpine Cemented Hip System?
Alpine Cemented Hip System is a medical device that received FDA 510(k) clearance on 2016-02-18. The listed applicant is Ortho Development Corporation. The 510(k) number is K153216.
When did Alpine Cemented Hip System receive FDA 510(k) clearance?
Alpine Cemented Hip System received FDA 510(k) clearance on 2016-02-18, under 510(k) number K153216.
Who is the listed applicant for Alpine Cemented Hip System?
The FDA 510(k) record lists Ortho Development Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Alpine Cemented Hip System?
The FDA product code for Alpine Cemented Hip System is JDI.
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。
列明Ortho Development Corporation为申报人的其他记录
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：JDI）
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。
K253515Zimmer Biomet OSS™ 骨科抢救系统 OsseoTi® 套管和增强件Biomet Orthopedics, Inc.K253434OSSTM骨科抢救系统Biomet, Inc.K252824Evolve AP 杯，世界鳍杯，世界 G-Zero 内衬和奇球股骨头Signature Orthopaedics Pty, Ltd.K243571trabecular金属髋臼翻修系统，髋臼衬垫和限制性衬垫Zimmer BiometK240783Anthology髋臼柄；CPCS髋臼柄；股骨头；R3髋臼衬垫；Spectron髋臼柄；Synergy髋臼柄Smith & Nephew, Inc.K241716全球模块化替换系统，模块化替换系统，模块化旋转铰链膝关节组件Howmedica Osteonics Corp., Dba Stryker Orthopaedics
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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