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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 K262963
Device Name TMC Implant 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 Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   JDR  
Date Received08/25/2026
Decision Date 09/15/2026
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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