FDA 510(k)

Meta+ 骨水泥 & M.U.S.T. 穿刺骨盆螺钉系统

K号: K241034 · 2024-06-12

决定日期2024-06-12

产品代码PML

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

Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2024-06-12 under 510(k) number K241034. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System?

Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2024-06-12. The listed applicant is Medacta International S.A.. The 510(k) number is K241034.

When did Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System receive FDA 510(k) clearance?

Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System received FDA 510(k) clearance on 2024-06-12, under 510(k) number K241034.

Who is the listed applicant for Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System?

FDA 510(k)记录将Medacta International S.A.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 Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System?

The FDA product code for Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System is PML.

列明Medacta International S.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。

K260173M-Vizion 髋关节翻修系统扩展 K253630Mpact 3D金属泡沫 K254202MectaLIF 3D金属前部 K253940M.U.S.T. Pedicle Screw System - Extension K253328GMK 3D金属胫骨托延长件 K250644MSS - 单块柄

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