FDA 510(k)

Talon 远端固定肱骨钉

K号: K173255 · 2018-02-22

申请人Orthopedic Designs North America, Inc.

决定日期2018-02-22

产品代码HSB

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

Talon DistalFix Humeral Nail is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Designs North America, Inc.. It received FDA 510(k) clearance on 2018-02-22 under 510(k) number K173255. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Talon DistalFix Humeral Nail?

Talon DistalFix Humeral Nail is a medical device that received FDA 510(k) clearance on 2018-02-22. The listed applicant is Orthopedic Designs North America, Inc.. The 510(k) number is K173255.

When did Talon DistalFix Humeral Nail receive FDA 510(k) clearance?

Talon DistalFix Humeral Nail received FDA 510(k) clearance on 2018-02-22, under 510(k) number K173255.

Who is the listed applicant for Talon DistalFix Humeral Nail?

The FDA 510(k) record lists Orthopedic Designs North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Talon DistalFix Humeral Nail?

The FDA product code for Talon DistalFix Humeral Nail is HSB.

列明Orthopedic Designs North America, Inc.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。

K210146Cannulated Compression Device System

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。