FDA 510(k)

VERASENSE for Stryker 三铁

K号: K200665 · 2020-04-12

决定日期2020-04-12

产品代码ONN

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决定实质等同

器械摘要

VERASENSE for Stryker Triathlon is the device name listed in this FDA 510(k) record. The listed applicant is Orthosensor, Inc.. It received FDA 510(k) clearance on 2020-04-12 under 510(k) number K200665. 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 Stryker Triathlon?

VERASENSE for Stryker Triathlon is a medical device that received FDA 510(k) clearance on 2020-04-12. The listed applicant is Orthosensor, Inc.. The 510(k) number is K200665.

When did VERASENSE for Stryker Triathlon receive FDA 510(k) clearance?

VERASENSE for Stryker Triathlon received FDA 510(k) clearance on 2020-04-12, under 510(k) number K200665.

Who is the listed applicant for VERASENSE for Stryker Triathlon?

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 Stryker Triathlon?

The FDA product code for VERASENSE for Stryker Triathlon is ONN.

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。

K200587VERASENSE 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 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 VERASENSE K180459Zimmer Biomet Persona 的 VERASENSE K150372VERASENSE膝关节系统

官方来源

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