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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 K200575
Device Name TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM
Applicant
Truemed Group, LLC
2002 Timberloch Pl., Suite 200
The Woodlands,  TX  77380
Applicant Contact Nina Galeana Rodriguez
Correspondent
Truemed Group, LLC
2002 Timberloch Pl., Suite 200
The Woodlands,  TX  77380
Correspondent Contact Nina Galeana Rodriguez
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received03/05/2020
Decision Date 07/09/2021
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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