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 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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-