FDA 510(k)

Freedom全膝关节系统（全聚乙烯胫骨板）

K号: K250382 · 2025-03-13

决定日期2025-03-13

产品代码JWH

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

Freedom Total Knee System (All-poly Tibial Plate) is the device name listed in this FDA 510(k) record. The listed applicant is Maxx Orthopedics, Inc.. It received FDA 510(k) clearance on 2025-03-13 under 510(k) number K250382. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Freedom Total Knee System (All-poly Tibial Plate)?

Freedom Total Knee System (All-poly Tibial Plate) is a medical device that received FDA 510(k) clearance on 2025-03-13. The listed applicant is Maxx Orthopedics, Inc.. The 510(k) number is K250382.

When did Freedom Total Knee System (All-poly Tibial Plate) receive FDA 510(k) clearance?

Freedom Total Knee System (All-poly Tibial Plate) received FDA 510(k) clearance on 2025-03-13, under 510(k) number K250382.

Who is the listed applicant for Freedom Total Knee System (All-poly Tibial Plate)?

FDA 510(k)记录将Maxx Orthopedics, Inc.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Freedom Total Knee System (All-poly Tibial Plate)?

The FDA product code for Freedom Total Knee System (All-poly Tibial Plate) is JWH.

列明Maxx Orthopedics, Inc.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。

K261563Freedom 全膝关节系统（E-Poly 股骨远端衬垫）K261609自由部分膝关节系统 K253171Libertas锥形短（TS）非骨水泥股骨柄（Libertas TS柄）K252777Freedom干骺端锥形植入物（干骺端锥）K253314Freedom Infinia®全膝关节系统 K253144Freedom® 全膝关节系统 – Titan PCK 组件

查看所有 19 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。