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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 K190830
Device Name TDM Screw Systems
Applicant
Tdm Co., Ltd.
69, Cheomdan Venture So-Ro, 37 Beon-Gil, Buk- Gu
Gwangju,  KR 61003
Applicant Contact Youngdae Kim
Correspondent
Lince Consulting, LLC
111 Deerwood Rd., Suite 200
San Ramon,  CA  94583
Correspondent Contact Sevrina Ciucci
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received04/01/2019
Decision Date 09/13/2019
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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