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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 K252961
Device Name Fusion FibFix Nail
Applicant
Fusion Orthopedics USA, LLC
6859 E Rembrandt Ave. Suite 122
Mesa,  AZ  85212
Applicant Contact Catalina Pardo
Correspondent
Fusion Orthopedics USA, LLC
6859 E Rembrandt Ave. Suite 122
Mesa,  AZ  85212
Correspondent Contact Catalina Pardo
Regulation Number888.3020
Classification Product Code
HSB  
Date Received09/16/2025
Decision Date 03/18/2026
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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