FDA 510(k)

VERASENSE膝关节系统

K号: K150372 · 2016-04-15

决定日期2016-04-15

产品代码ONN

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决定实质等同

器械摘要

VERASENSE Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Orthosensor, Inc.. It received FDA 510(k) clearance on 2016-04-15 under 510(k) number K150372. 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 Knee System?

VERASENSE Knee System is a medical device that received FDA 510(k) clearance on 2016-04-15. The listed applicant is Orthosensor, Inc.. The 510(k) number is K150372.

When did VERASENSE Knee System receive FDA 510(k) clearance?

VERASENSE Knee System received FDA 510(k) clearance on 2016-04-15, under 510(k) number K150372.

Who is the listed applicant for VERASENSE Knee System?

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 Knee System?

The FDA product code for VERASENSE Knee System 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 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 VERASENSE K180459Zimmer Biomet Persona 的 VERASENSE

官方来源

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