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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K250923
Device Name Fine Osteotomy™
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
HRS  
Subsequent Product Codes
HWC   PBF  
Date Received03/27/2025
Decision Date 08/21/2025
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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