FDA 510(k)

VELYS™ 髋关节导航

K号: K253551 · 2026-03-06

决定日期2026-03-06

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

VELYS™ Hip Navigation 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 2026-03-06 under 510(k) number K253551. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VELYS™ Hip Navigation?

VELYS™ Hip Navigation is a medical device that received FDA 510(k) clearance on 2026-03-06. The listed applicant is Depuy Ireland UC. The 510(k) number is K253551.

When did VELYS™ Hip Navigation receive FDA 510(k) clearance?

VELYS™ Hip Navigation received FDA 510(k) clearance on 2026-03-06, under 510(k) number K253551.

Who is the listed applicant for VELYS™ Hip Navigation?

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™ Hip Navigation?

The FDA product code for VELYS™ Hip Navigation is QIH.

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。

K261458ATTUNE Total Knee System; ATTUNE Cementless Knee System K260480VELYS™ 机器人辅助解决方案 K260536Prostalac髋关节系统，SmartSet V+G双抗生素骨水泥 K253624INHANCE™ Reverse Shoulder System K253197ATTUNE™ 全膝关节系统；ATTUNE™ 修正型袖套LPS™ 股骨适配器 K251292RECLAIM Monobloc Revision Femoral Stem

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官方来源

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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。