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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 K251135
Device Name Treace Medical Concepts (TMC) Implant Fixation System
Applicant
Treace Medical Concepts
100 Palmetto Park Pl.
Ponte Vedra,  FL  32081
Applicant Contact Brittany Grochala
Correspondent
Treace Medical Concepts
100 Palmetto Park Pl.
Ponte Vedra,  FL  32081
Correspondent Contact Brittany Grochala
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HWC   JDR  
Date Received04/14/2025
Decision Date 08/21/2025
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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