EVOS 连接系统
K号: K201497 · 2020-10-28
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决定日期2020-10-28
产品代码JDQ
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：
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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]
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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
EVOS Cabling System is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). It received FDA 510(k) clearance on 2020-10-28 under 510(k) number K201497. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EVOS Cabling System?
EVOS Cabling System is a medical device that received FDA 510(k) clearance on 2020-10-28. The listed applicant is Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). The 510(k) number is K201497.
When did EVOS Cabling System receive FDA 510(k) clearance?
EVOS Cabling System received FDA 510(k) clearance on 2020-10-28, under 510(k) number K201497.
Who is the listed applicant for EVOS Cabling System?
The FDA 510(k) record lists Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EVOS Cabling System?
The FDA product code for EVOS Cabling System is JDQ.
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。
列明Pioneer Surgical Technology, Inc. (Dba Rti Surgical, 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。
K200095Streamline导航工具K193468三氚胸骨电缆板系统K192800Streamline TL脊柱固定系统K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyK190498Fortilink® IBF System with TETRAfuse®3D Technology，包括以下设计：Fortilink®-TS IBF System，Fortilink®-L I BF System，Fortilink®-C IBF SystemK183060CervAlign™ 前颈椎板系统
相关器械（代码：JDQ）
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。
K261271Cable-Ready® 电缆夹持系统Pioneer Surgical Technology, Inc.K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.K243344Arthrex 纤维带和 TigerTape 结扎缝合线；Arthrex 透视纤维带结扎缝合线Arthrex, Inc.K232733Mbrace电缆Medacta International S.A.K233949ACCORD 电缆系统Smith & Nephew, Inc.K232986VariTrax 胸骨环绕固定系统Circumfix Solutions, Inc.
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。
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