Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K260480
Device Name VELYS™ Robotic-Assisted Solution
Applicant
Depuy Ireland UC
Loughbeg
Ringaskiddy, Co. Cork,  IE
Applicant Contact Camille Chua
Correspondent
Depuy Ireland UC
Loughbeg
Ringaskiddy, Co. Cork,  IE
Correspondent Contact Taylen Curenton
Regulation Number882.4560
Classification Product Code
OLO  
Date Received02/13/2026
Decision Date 06/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-