FDA 510(k)

I.T.S. INS 近端股骨钉

K号: K233134 · 2024-02-12

决定日期2024-02-12

产品代码HSB

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

I.T.S. INS Proximal Femur Nail is the device name listed in this FDA 510(k) record. The listed applicant is I.T.S. GmbH. It received FDA 510(k) clearance on 2024-02-12 under 510(k) number K233134. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the I.T.S. INS Proximal Femur Nail?

I.T.S. INS Proximal Femur Nail is a medical device that received FDA 510(k) clearance on 2024-02-12. The listed applicant is I.T.S. GmbH. The 510(k) number is K233134.

When did I.T.S. INS Proximal Femur Nail receive FDA 510(k) clearance?

I.T.S. INS Proximal Femur Nail received FDA 510(k) clearance on 2024-02-12, under 510(k) number K233134.

Who is the listed applicant for I.T.S. INS Proximal Femur Nail?

The FDA 510(k) record lists I.T.S. GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I.T.S. INS Proximal Femur Nail?

The FDA product code for I.T.S. INS Proximal Femur Nail is HSB.

列明I.T.S. GmbH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。

K260958I.T.S. 角度稳定性锁骨板；I.T.S. 角度稳定性掌骨板；I.T.S. 角度稳定性肱骨头板；I.T.S. FR.O.H. 距骨修复系统；I.T.S. 角度稳定性跟骨板；I.T.S. 角度稳定性尺骨鹰嘴板；I.T.S. 角度稳定性直板；I.T.S. 螺钉系统；I.T.S. PRS 椎骨棒系统；I.T.S. Fibula Plate PROlock 角度稳定性；I.T.S. 角度稳定性远端肱骨板；I.T.S. LRS（L）K260054I.T.S. PRS Phoenix II K210935I.T.S. 盆腔重建系统（PRS RX & PRS Phoenix）

官方来源

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