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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K253108
Device Name VEOFIX Snap Off Screw
Applicant
Steps Ortho
3 Allée Des Ginkgos
Bron,  FR 69500
Applicant Contact Morgane Grenier
Correspondent
MRC Global, LLC
9085 E. Mineral Cir., Suite 110
Centennial,,  CO  80112
Correspondent Contact Christine Scifert
Regulation Number888.3040
Classification Product Code
HWC  
Date Received09/24/2025
Decision Date 06/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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