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FDA 510(k)

SMR 肩关节系统；PRIMA 盂系统；PRIMA 肱骨系统

K号: K252352 · 2026-01-22

申请人Lima Corporate S.P.A.
决定日期2026-01-22
产品代码PHX
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

SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System 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 2026-01-22 under 510(k) number K252352. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System?

SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System is a medical device that received FDA 510(k) clearance on 2026-01-22. The listed applicant is Lima Corporate S.P.A.. The 510(k) number is K252352.

When did SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System receive FDA 510(k) clearance?

SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System received FDA 510(k) clearance on 2026-01-22, under 510(k) number K252352.

Who is the listed applicant for SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System?

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 SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System?

The FDA product code for SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System is PHX.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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。

K251718ArTT Augments and Buttresses and Bone ScrewsK243826SMR 反向 HP 肩关节系统K250980Physica系统 (Physica CR多孔股骨组件)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 →

相关器械（代码：PHX）

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。

K260556Veritas肩部系统Restor3DK261683Augment 偏轴仪器系统Zimmer, Inc.K260102Tornier Perform 反向鹅颈和Tornier Perform 反向增强鹅颈肩关节系统Stryker Corporation (Tornier, Inc.)K261016MSS - 肱骨反向衬垫延长件Medacta International, SAK253992Veritas 逆转全肩关节系统Restor3DK252404综合反向肩关节 - HA股骨头底板Biomet Orthopedics

官方来源

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