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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 K213036
Device Name Treace Medical Concepts (TMC) Screw Fixation System
Applicant
Treace Medical Concepts, Inc.
203 Fort Wade Rd., Suite 150
Ponte Vedra,  FL  32081
Applicant Contact Kristina Hall
Correspondent
MRC Global, LLC
9085 E Mineral Circle, Suite 110
Centennial,  CO  80112
Correspondent Contact Danielle Besal
Regulation Number888.3040
Classification Product Code
HWC  
Date Received09/21/2021
Decision Date 10/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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