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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 K190391
Device Name TDM Plate and Screw Systems
Applicant
Tdm Co., Ltd.
69, Cheomdan Venture So-Ro, 37 Beon-Gil, Buk- Gu
Gwangju,  KR 61003
Applicant Contact Yougdae Kim
Correspondent
Lince Consulting, LLC
111 Deerwood Rd., Suite 200
San Ramon,  CA  94583
Correspondent Contact Sevrina Ciucci
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received02/19/2019
Decision Date 11/15/2019
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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