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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 K231343
Device Name Redemption Duo Hindfoot Nail System
Applicant
Vilex, LLC
111 Moffitt St.
Mcminnville,  TN  37110
Applicant Contact Brock Johnson
Correspondent
Vilex, LLC
111 Moffitt St.
Mcminnville,  TN  37110
Correspondent Contact Brock Johnson
Regulation Number888.3020
Classification Product Code
HSB  
Date Received05/09/2023
Decision Date 01/30/2024
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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