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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 K254280
Device Name F.A.S.T Screw
Applicant
Steps Ortho
3 Allée Des Ginkgos
Bron,  FR 69500
Applicant Contact Morgane Grenier
Correspondent
MRC Global, LLC
9160 Hwy. 64, Suite 12
P.O. Box 330
Lakeland,  TN  38002
Correspondent Contact Christine Scifert
Regulation Number888.3040
Classification Product Code
HWC  
Date Received12/30/2025
Decision Date 09/21/2026
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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