Traufix 骨固定、截骨和关节融合设备
K号: K201510 · 2022-02-18
广告
决定日期2022-02-18
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
Traufix osteosynthesis, osteotomy, and arthrodesis devices is the device name listed in this FDA 510(k) record. The listed applicant is Fixier S.A. DE C.V.. It received FDA 510(k) clearance on 2022-02-18 under 510(k) number K201510. 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 Traufix osteosynthesis, osteotomy, and arthrodesis devices?
Traufix osteosynthesis, osteotomy, and arthrodesis devices is a medical device that received FDA 510(k) clearance on 2022-02-18. The listed applicant is Fixier S.A. DE C.V.. The 510(k) number is K201510.
When did Traufix osteosynthesis, osteotomy, and arthrodesis devices receive FDA 510(k) clearance?
Traufix osteosynthesis, osteotomy, and arthrodesis devices received FDA 510(k) clearance on 2022-02-18, under 510(k) number K201510.
Who is the listed applicant for Traufix osteosynthesis, osteotomy, and arthrodesis devices?
The FDA 510(k) record lists Fixier S.A. DE C.V. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Traufix osteosynthesis, osteotomy, and arthrodesis devices?
The FDA product code for Traufix osteosynthesis, osteotomy, and arthrodesis devices is HRS.
相关临床试验
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。
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 TechnologiesK262963TMC植入固定系统Treace Medical Concepts, Inc.K261647Tempo电镀系统；超压缩螺钉系统Pace SurgicalK261830FRAXION 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 SirketiK262537Versalock无菌敷贴系统GM Dos Reis Industria e Comercio Ltda.
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。
广告