FDA 510(k)

dynaMX™ 尼龙奥压缩螺钉

K号: K160427 · 2016-06-03

决定日期2016-06-03

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

dynaMX(TM) Nitinol Compression Screw is the device name listed in this FDA 510(k) record. The listed applicant is Mx Orthopedics, Corp.. It received FDA 510(k) clearance on 2016-06-03 under 510(k) number K160427. 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 dynaMX(TM) Nitinol Compression Screw?

dynaMX(TM) Nitinol Compression Screw is a medical device that received FDA 510(k) clearance on 2016-06-03. The listed applicant is Mx Orthopedics, Corp.. The 510(k) number is K160427.

When did dynaMX(TM) Nitinol Compression Screw receive FDA 510(k) clearance?

dynaMX(TM) Nitinol Compression Screw received FDA 510(k) clearance on 2016-06-03, under 510(k) number K160427.

Who is the listed applicant for dynaMX(TM) Nitinol Compression Screw?

The FDA 510(k) record lists Mx Orthopedics, Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for dynaMX(TM) Nitinol Compression Screw?

The FDA product code for dynaMX(TM) Nitinol Compression Screw is HWC. This falls under the Cardiovascular category.

列明Mx Orthopedics, 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。

K161303dynaMX™ 压缩板 K153129dynaMX 分页式钉合器

官方来源

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