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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 K241128
Device Name TDM Plate and Screw System
Applicant
Tdm Co., Ltd.
69, Cheomdan Venture So-Ro, 37 Beon-Gil, Buk- Gu
Gwangju,  KR 61003
Applicant Contact Jungwook Choi
Correspondent
Eerkie Corporation
4027 Runnymeade Dr.
Collegeville,  PA  19426
Correspondent Contact Jeena Mathai
Regulation Number888.3030
Classification Product Code
HRS  
Date Received04/24/2024
Decision Date 12/05/2024
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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