VELYS Hip Navigation— 510(k) K253551

Substantially Equivalent

Depuy Ireland UC

FDA 510(k) clearance K253551 for VELYS Hip Navigation, Substantially Equivalent on 2026-03-06. Applicant: Depuy Ireland UC. Device class: 2.

Clearance details

Applicant: Depuy Ireland UC
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-11-14
Decision date: 2026-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ringaskiddy, Co. Cork, IE

Download summary PDF View on FDA.gov ↗

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