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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 K240173
Device Name Treace Medical Systems (TMC) Plating 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 Code
HWC  
Date Received01/23/2024
Decision Date 02/22/2024
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
Recalls CDRH Recalls
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