FDA 510(k)

U2 全膝关节系统 – PF+ 髌骨；USTAR II 系统 – PF+ 髌骨

K号: K243656 · 2025-07-31

决定日期2025-07-31

产品代码MBH

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： --- 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] --- 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

U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella is the device name listed in this FDA 510(k) record. The listed applicant is United Orthopedic Corporation. It received FDA 510(k) clearance on 2025-07-31 under 510(k) number K243656. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella?

U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella is a medical device that received FDA 510(k) clearance on 2025-07-31. The listed applicant is United Orthopedic Corporation. The 510(k) number is K243656.

When did U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella receive FDA 510(k) clearance?

U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella received FDA 510(k) clearance on 2025-07-31, under 510(k) number K243656.

Who is the listed applicant for U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella?

FDA 510(k)记录中列出联合骨科公司为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella?

The FDA product code for U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella is MBH.

列明United Orthopedic 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。

K253948动量髋臼杯系统 K252725Stem扩展线(U2全膝关节系统—PSA类型)K252303Stem扩展线(USTAR II系统)K242315Resolve 模块化髋关节假体柄 K243466合规茎延长线，#0 K243024Cellbrick膝关节间隙垫

查看所有 27 个设备 →

官方来源

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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。