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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K254182
Device Name Aster
Applicant
Osteonic Co., Ltd.
405ho,505-2ho,505-3ho,508ho,603ho,902ho,1004ho,1005ho,1103ho
12f, 38, Digital-Ro 29-Gil, Guro-Gu 102ho, 103ho,105ho, 24
Seoul,  KR 08381
Applicant Contact Jisun Lee
Correspondent
Osteonic Co., Ltd.
405ho,505-2ho,505-3ho,508ho,603ho,902ho,1004ho,1005ho,1103ho
12f, 38, Digital-Ro 29-Gil, Guro-Gu 102ho, 103ho,105ho, 24
Seoul,  KR 08381
Correspondent Contact Jisun Lee
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received12/23/2025
Decision Date 02/26/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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