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FDA 510(k)

VERASENSE for Exactech Equinoxe 尺寸 38 mm，VERASENSE for Exactech Equinoxe 尺寸 42 mm，LinkStation MINI，LinkStation MINI 评估套件，VERASENSE 肩关节软件应用

K号: K200587 · 2020-08-25

申请人Orthosensor, Inc.
决定日期2020-08-25
产品代码ONN
咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同

器械摘要

VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder is the device name listed in this FDA 510(k) record. The listed applicant is Orthosensor, Inc.. It received FDA 510(k) clearance on 2020-08-25 under 510(k) number K200587. The device is classified under product code ONN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder?

VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder is a medical device that received FDA 510(k) clearance on 2020-08-25. The listed applicant is Orthosensor, Inc.. The 510(k) number is K200587.

When did VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder receive FDA 510(k) clearance?

VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder received FDA 510(k) clearance on 2020-08-25, under 510(k) number K200587.

Who is the listed applicant for VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder?

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

What is the FDA product code for VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder?

The FDA product code for VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder is ONN.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Orthosensor, 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。

K200665VERASENSE for Stryker 三铁K193580Zimmer Biomet Persona CR C-D/3-9 左侧 VERASENSE，Zimmer Biomet Persona CR C-D/3-9 右侧 VERASENSE，Zimmer Biomet Persona CR E-F/3-11 左侧 VERASENSE，Zimmer Biomet Persona CR E-F/3-11 右侧 VERASENSE，Zimmer Biomet Persona CR G-H/7-12 左侧 VERASENSEK180459Zimmer Biomet Persona 的 VERASENSEK150372VERASENSE膝关节系统

相关器械（代码：ONN）

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。

K262253灯笼膝关节导航单元（406000-03）；灯笼髋关节导航单元（502000-03）Orthalign, Inc.K253507包装组件，可重复使用的导航单元；Lantern ASC，智能包装套件，膝关节Orthalign, Inc.K252524Quadsense (Quadsense and Quadsense Pro)Eventum Orthopaedics, Ltd.K241298QUADSENSEEventum Orthopaedics, Ltd.K242616Lantern® 髋关节Orthalign, Inc.K220830TrueBalance™ 手术系统These Three Medical, LLC

官方来源

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