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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K260361
Device Name Treace Medical Concepts (TMC) Screw Fixation System
Applicant
Treace Medical Concepts, Inc.
100 Palmetto Park Pl.
Ponte Vedra,  FL  32081
Applicant Contact Melissa Coloroso
Correspondent
Treace Medical Concepts, Inc.
100 Palmetto Park Pl.
Ponte Vedra,  FL  32081
Correspondent Contact Melissa Coloroso
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HRS  
Date Received02/04/2026
Decision Date 03/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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