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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 K261189
Device Name Freedom Nail Ankle Fusion System
Applicant
McGinley Orthopaedic Innovations
234 E. 1st St. Suite 242
Casper,  WY  82601
Applicant Contact Adam Johnson
Correspondent
MCRA, LLC
803 7th St., NW
Washington,  DC  20001
Correspondent Contact Hannah Irwin
Regulation Number888.3020
Classification Product Code
HSB  
Date Received04/10/2026
Decision Date 10/19/2026
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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