假肢，膝关节，股骨胫骨，单间室，半限制型，金属/聚合物，活动轴承
PMA编号：P010014 · 2026-09-01
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决定日期2026-09-01
PMA 编号P010014
产品代码NRA
设备分类第3类
医疗专科U
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。
器械摘要
Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2026-09-01. The device is classified under product code NRA. It was reviewed by the OR advisory panel.
常见问题
What is the Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing?
Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing is a medical device that received FDA 510(k) clearance on 2026-09-01. The listed applicant is Biomet Manufacturing Corp.
When did Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing receive FDA 510(k) clearance?
The clearance date for Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing can be found in the official FDA records.
谁是被列出的假肢、膝关节、股胫关节、单间室、半限制性、金属/聚合物、活动轴承的申请人？
The FDA 510(k) record lists Biomet Manufacturing Corp as the applicant. This does not by itself establish the device manufacturer.
什么是FDA假肢产品代码，用于膝关节、股骨胫骨、单间室、半限制性、金属/聚合物、活动轴承？
FDA产品代码为膝关节假体（股骨胫骨，单间室，半限制性，金属/聚合物，活动轴承）的为NRA。
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。
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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