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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthopedic stereotaxic instrument
510(k) Number K202769
Device Name VELYS™ Robotic-Assisted Solution
DePuy Ireland UC
Ringaskiddy,  IE
Applicant Contact Erin Combs
DePuy Ireland UC
Ringaskiddy,  IE
Correspondent Contact Stephanie Elvin
Regulation Number882.4560
Classification Product Code
Date Received09/21/2020
Decision Date 01/14/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls