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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 K222564
Device Name Treace Medical Concepts (TMC) Hammertoe Fixation System
Applicant
Treace Medical Concepts, Inc.
203 Fort Wade Rd., Suite 150
Ponte Vedra,  FL  32081
Applicant Contact Kristina Hall
Correspondent
MRC Global
9085 E. Mineral Cir., Suite 110
Centennial,,  CO  80112
Correspondent Contact Danielle Besal
Regulation Number888.3040
Classification Product Code
HWC  
Date Received08/24/2022
Decision Date 11/15/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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