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