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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Fixation, Threaded
510(k) Number K250316
Device Name Meduloc Intramedullary Fracture Fixation (IFF) System
Applicant
Meduloc, LLC
2010 Jimmy Durante Blvd., Suite 200
Del Mar,  CA  92014
Applicant Contact Benjamin Arnold
Correspondent
Meduloc, LLC
2010 Jimmy Durante Blvd., Suite 200
Del Mar,  CA  92014
Correspondent Contact Benjamin Arnold
Regulation Number888.3040
Classification Product Code
JDW  
Subsequent Product Codes
HTY   HWC  
Date Received02/04/2025
Decision Date 10/29/2025
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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