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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopaedic Surgical Planning And Instrument Guides
510(k) Number K250394
Device Name Fine TTO™
Applicant
Bodycad Laboratories, Inc.
2035 Rue Du Haut-Bord
Quebec,  CA G1N4R7
Applicant Contact Nadine Adia
Correspondent
Bodycad Laboratories, Inc.
2035 Rue Du Haut-Bord
Quebec,  CA G1N4R7
Correspondent Contact Nadine Adia
Regulation Number888.3030
Classification Product Code
PBF  
Subsequent Product Code
HWC  
Date Received02/12/2025
Decision Date 10/21/2025
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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