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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Integrated Fixation, Cervical
510(k) Number K260036
Device Name NeckTune™ 3D SA Cervical Cage
Applicant
Medyssey Co, Ltd.
129 Hanbang Expo-Ro
Jecheon-Si,  KR 27116
Applicant Contact Hyokyeong Lee
Correspondent
Medyssey Co, Ltd.
129 Hanbang Expo-Ro
Jecheon-Si,  KR 27116
Correspondent Contact Hyokyeong Lee
Regulation Number888.3080
Classification Product Code
OVE  
Subsequent Product Code
ODP  
Date Received01/06/2026
Decision Date 06/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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