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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K253517
Device Name Reselute Tibial Nail
Applicant
Reselute, Inc.
701 W Main St.
Suite 410
Durham,  NC  27701
Applicant Contact Brianna Prindle
Correspondent
Reselute, Inc.
701 W Main St.
Suite 410
Durham,  NC  27701
Correspondent Contact Brianna Prindle
Regulation Number888.3020
Classification Product Code
HSB  
Date Received11/12/2025
Decision Date 03/10/2026
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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