FDA 510(k)

SMR 混合盂系统

K号: K231099 · 2023-12-21

决定日期2023-12-21

产品代码MBF

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 Hybrid Glenoid 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 2023-12-21 under 510(k) number K231099. The device is classified under product code MBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SMR Hybrid Glenoid System?

SMR Hybrid Glenoid System is a medical device that received FDA 510(k) clearance on 2023-12-21. The listed applicant is Lima Corporate S.P.A.. The 510(k) number is K231099.

When did SMR Hybrid Glenoid System receive FDA 510(k) clearance?

SMR Hybrid Glenoid System received FDA 510(k) clearance on 2023-12-21, under 510(k) number K231099.

Who is the listed applicant for SMR Hybrid Glenoid 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 Hybrid Glenoid System?

The FDA product code for SMR Hybrid Glenoid System is MBF.

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 K250980Physica系统 (Physica CR多孔股骨组件)K243615Physica多孔股骨组件 K234011AMF TT 锥

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官方来源

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