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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Cervical Screw System
510(k) Number K251725
Device Name ANAX™ OCT Spinal System
Applicant
Cg Medtech Co., Ltd.
20, Sandan-Ro 76 Beon-Gil(Rd)
Uijeongbu-Si,  KR 11781
Applicant Contact Jeongah Kim
Correspondent
Cg Medtech Co., Ltd.
20, Sandan-Ro 76 Beon-Gil(Rd)
Uijeongbu-Si,  KR 11781
Correspondent Contact Jeongah Kim
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received06/05/2025
Decision Date 06/25/2025
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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