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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 K231860
Device Name TDM Screw System
Applicant
Tdm Co., Ltd.
69, Cheomdan Venture So-Ro
37 Beon-Gil
Buk-Gu,  KR 61003
Applicant Contact Jung Wook Choi
Correspondent
Eerkie Corporation
4027 Runnymeade Dr.
Collegeville,  PA  19426
Correspondent Contact Jeena Mathai
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/23/2023
Decision Date 01/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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