FDA 510(k)

PediFlex 弹性钉系统

K号: K201838 · 2021-01-29

决定日期2021-01-29

产品代码HTY

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

PediFlex Flexible Nail System is the device name listed in this FDA 510(k) record. The listed applicant is OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2021-01-29 under 510(k) number K201838. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PediFlex Flexible Nail System?

PediFlex Flexible Nail System is a medical device that received FDA 510(k) clearance on 2021-01-29. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K201838.

When did PediFlex Flexible Nail System receive FDA 510(k) clearance?

PediFlex Flexible Nail System received FDA 510(k) clearance on 2021-01-29, under 510(k) number K201838.

Who is the listed applicant for PediFlex Flexible Nail System?

FDA 510(k)记录将OrthoPediatrics Corp.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 PediFlex Flexible Nail System?

The FDA product code for PediFlex Flexible Nail System is HTY.

列明OrthoPediatrics Corp.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。

K261345儿童接骨平台股骨 K260323OrthoPediatrics® Locking Cannulated Blade Plate System K252600儿童小型-迷你平台 K251362PediFlex™ 弹性钉系统 K243963儿童髋关节平台 K250623儿童接骨平台胫骨儿童接骨平台股骨

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官方来源

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