FDA 510(k)

Bicortical 固定螺钉及垫圈系统

K号: K153638 · 2016-04-19

决定日期2016-04-19

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

Bicortical Fixation Screw & Washer Nut System is the device name listed in this FDA 510(k) record. The listed applicant is First Ray, LLC. It received FDA 510(k) clearance on 2016-04-19 under 510(k) number K153638. 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 Bicortical Fixation Screw & Washer Nut System?

Bicortical Fixation Screw & Washer Nut System is a medical device that received FDA 510(k) clearance on 2016-04-19. The listed applicant is First Ray, LLC. The 510(k) number is K153638.

When did Bicortical Fixation Screw & Washer Nut System receive FDA 510(k) clearance?

Bicortical Fixation Screw & Washer Nut System received FDA 510(k) clearance on 2016-04-19, under 510(k) number K153638.

Who is the listed applicant for Bicortical Fixation Screw & Washer Nut System?

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

What is the FDA product code for Bicortical Fixation Screw & Washer Nut System?

The FDA product code for Bicortical Fixation Screw & Washer Nut System is HWC. This falls under the Cardiovascular category.

列明First Ray, 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。

K163440Stealth打结系统 K153585Flip按钮缝合锚 K153622First Ray 内部骨板钉系统

官方来源

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