FDA 510(k)

Javelin 尾指锤状趾固定系统

K号: K202657 · 2020-12-14

申请人Nvision Biomedical Technologies, Inc.

决定日期2020-12-14

产品代码HRS

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

Javelin Tailor's Bunion Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2020-12-14 under 510(k) number K202657. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Javelin Tailor's Bunion Fixation System?

Javelin Tailor's Bunion Fixation System is a medical device that received FDA 510(k) clearance on 2020-12-14. The listed applicant is Nvision Biomedical Technologies, Inc.. The 510(k) number is K202657.

When did Javelin Tailor's Bunion Fixation System receive FDA 510(k) clearance?

Javelin Tailor's Bunion Fixation System received FDA 510(k) clearance on 2020-12-14, under 510(k) number K202657.

Who is the listed applicant for Javelin Tailor's Bunion Fixation System?

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

What is the FDA product code for Javelin Tailor's Bunion Fixation System?

The FDA product code for Javelin Tailor's Bunion Fixation System is HRS.

列明Nvision Biomedical Technologies, 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。

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相关器械（代码：HRS）

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。

K261892ProRib 固定系统Costa Surgical, Inc.K262098增强型聚醚醚酮（PEEK）拇外翻矫正系统Nvision Biomedical Technologies K262963TMC植入固定系统Treace Medical Concepts, Inc.K261647Tempo电镀系统；超压缩螺钉系统Pace Surgical K261830FRAXION 3.5 板系统（多种 - 见目录）；FRAXION 4.5 板系统（多种 - 见目录）；FRAXION 迷你板系统（多种 - 见目录）；FRAXION 骨螺钉系统（多种 - 见目录）Ortler Global Tibbi Gerecler Anonim Sirketi K262537Versalock无菌敷贴系统GM Dos Reis Industria e Comercio Ltda.

官方来源

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