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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K263062
Device Name NOVIX Pedicle Screw System
Applicant
Tdm Co., Ltd.
69, Cheomdan Venture So-Ro, 37 Beon-Gil, Buk- Gu
Gwangju,  KR 61003
Applicant Contact Jungwook Choi
Correspondent
Tdm Co., Ltd.
69, Cheomdan Venture So-Ro, 37 Beon-Gil, Buk- Gu
Gwangju,  KR 61003
Correspondent Contact Suji Jung
Regulation Number888.3070
Classification Product Code
NKB  
Date Received09/01/2026
Decision Date 10/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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