FDA 510(k)

VELYS™ 机器人辅助解决方案

K号: K233227 · 2023-12-14

决定日期2023-12-14

产品代码OLO

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

VELYS™ Robotic-Assisted Solution is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2023-12-14 under 510(k) number K233227. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VELYS™ Robotic-Assisted Solution?

VELYS™ Robotic-Assisted Solution is a medical device that received FDA 510(k) clearance on 2023-12-14. The listed applicant is Depuy Ireland UC. The 510(k) number is K233227.

When did VELYS™ Robotic-Assisted Solution receive FDA 510(k) clearance?

VELYS™ Robotic-Assisted Solution received FDA 510(k) clearance on 2023-12-14, under 510(k) number K233227.

Who is the listed applicant for VELYS™ Robotic-Assisted Solution?

The FDA 510(k) record lists Depuy Ireland UC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VELYS™ Robotic-Assisted Solution?

The FDA product code for VELYS™ Robotic-Assisted Solution is OLO.

列明Depuy Ireland UC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。

K260480VELYS™ 机器人辅助解决方案 K261458ATTUNE Total Knee System; ATTUNE Cementless Knee System K260536Prostalac髋关节系统，SmartSet V+G双抗生素骨水泥 K253624INHANCE™ Reverse Shoulder System K253551VELYS™ 髋关节导航 K253197ATTUNE™ 全膝关节系统；ATTUNE™ 修正型袖套LPS™ 股骨适配器

查看所有 50 个设备 →

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。