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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 K183363
Device Name Treace Medical Concepts (TMC) Snap-Off Screw System
Applicant
Treace Medical Concepts, Inc.
203 Fort Wade Rd., Suite 150
Ponte Vedra,  FL  32081
Applicant Contact Rachel Osbeck
Correspondent
Mrc-X, LLC
6075 Poplar Ave., Suite 500
Memphis,  TN  38119
Correspondent Contact Dawn Norman
Regulation Number888.3040
Classification Product Code
HWC  
Date Received12/04/2018
Decision Date 06/13/2019
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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