FDA 510(k)

MIS 精确斜坡脚趾骨刺系统

K号: K211628 · 2022-01-31

决定日期2022-01-31

产品代码HWC

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

MIS Precision Chevron Bunion System is the device name listed in this FDA 510(k) record. The listed applicant is Relja Innovations, LLC. It received FDA 510(k) clearance on 2022-01-31 under 510(k) number K211628. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the MIS Precision Chevron Bunion System?

MIS Precision Chevron Bunion System is a medical device that received FDA 510(k) clearance on 2022-01-31. The listed applicant is Relja Innovations, LLC. The 510(k) number is K211628.

When did MIS Precision Chevron Bunion System receive FDA 510(k) clearance?

MIS Precision Chevron Bunion System received FDA 510(k) clearance on 2022-01-31, under 510(k) number K211628.

Who is the listed applicant for MIS Precision Chevron Bunion System?

FDA 510(k)记录中列出Relja Innovations, LLC为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for MIS Precision Chevron Bunion System?

The FDA product code for MIS Precision Chevron Bunion System is HWC. This falls under the Cardiovascular category.

列明Relja Innovations, LLC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。

K262075拉皮杜斯螺钉套装

官方来源

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