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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 K251913
Device Name OsteoCentric® UnifiMI® TCS Plating System
Applicant
OsteoCentric Technologies
75 W. 300 N.
Suite 150
Logan,  UT  84321
Applicant Contact Todd Evans
Correspondent
OsteoCentric Technologies
75 W. 300 N.
Suite 150
Logan,  UT  84321
Correspondent Contact Todd Evans
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received06/23/2025
Decision Date 08/16/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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