VELYS Hip Navigation
K-Number: K253551 · 2026-03-06
ApplicantDepuy Ireland UC
Decision Date2026-03-06
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
VELYS Hip Navigation is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2026-03-06 under approval number K253551. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VELYS Hip Navigation?
VELYS Hip Navigation is a medical device that received FDA 510(k) clearance on 2026-03-06. It is manufactured by Depuy Ireland UC. The 510(k) number is K253551.
When was VELYS Hip Navigation approved by the FDA?
VELYS Hip Navigation received FDA 510(k) clearance on 2026-03-06, under approval number K253551.
What company makes VELYS Hip Navigation?
VELYS Hip Navigation is manufactured by Depuy Ireland UC.
What is the FDA product code for VELYS Hip Navigation?
The FDA product code for VELYS Hip Navigation is QIH.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.