FDA 510(k)

Physica系统 (Physica CR多孔股骨组件)

K号: K250980 · 2025-05-22

决定日期2025-05-22

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

Physica System (Physica CR Porous Femoral components) is the device name listed in this FDA 510(k) record. The listed applicant is Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2025-05-22 under 510(k) number K250980. 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 Physica System (Physica CR Porous Femoral components)?

Physica System (Physica CR Porous Femoral components) is a medical device that received FDA 510(k) clearance on 2025-05-22. The listed applicant is Lima Corporate S.P.A.. The 510(k) number is K250980.

When did Physica System (Physica CR Porous Femoral components) receive FDA 510(k) clearance?

Physica System (Physica CR Porous Femoral components) received FDA 510(k) clearance on 2025-05-22, under 510(k) number K250980.

Who is the listed applicant for Physica System (Physica CR Porous Femoral components)?

The FDA 510(k) record lists Lima Corporate S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Physica System (Physica CR Porous Femoral components)?

The FDA product code for Physica System (Physica CR Porous Femoral components) is MBH.

列明Lima Corporate S.P.A.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。

K252352SMR 肩关节系统；PRIMA 盂系统；PRIMA 肱骨系统 K251718ArTT Augments and Buttresses and Bone Screws K243826SMR 反向 HP 肩关节系统 K243615Physica多孔股骨组件 K234011AMF TT 锥 K233712PRIMA 肱骨系统；PRIMA TT 肩臼

查看所有 41 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。