FDA 510(k)

Healix® 压缩螺钉系统

K号: K182949 · 2018-12-04

决定日期2018-12-04

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

Healix™ Compression Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies, LLC. It received FDA 510(k) clearance on 2018-12-04 under 510(k) number K182949. 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 Healix™ Compression Screw System?

Healix™ Compression Screw System is a medical device that received FDA 510(k) clearance on 2018-12-04. The listed applicant is Nvision Biomedical Technologies, LLC. The 510(k) number is K182949.

When did Healix™ Compression Screw System receive FDA 510(k) clearance?

Healix™ Compression Screw System received FDA 510(k) clearance on 2018-12-04, under 510(k) number K182949.

Who is the listed applicant for Healix™ Compression Screw System?

The FDA 510(k) record lists Nvision Biomedical Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Healix™ Compression Screw System?

The FDA product code for Healix™ Compression Screw System is HWC. This falls under the Cardiovascular category.

列明Nvision Biomedical Technologies, 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。

K182943VERTEX 尼龙奥氏体钉系统 K183055Vector锤状趾矫正系统 K180458FOCUS 椎弓根螺钉系统 K173091Boundary前腰椎支撑板 K170074nvc 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行准确的翻译。如果您能提供具体的文本内容，我将能够为您提供准确的翻译。K162426nva，nvp，和nvt

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