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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 Bone Graft, Cervical
510(k) Number K253041
Device Name 3d Cage Cervical
Applicant
Fims Co., Ltd.
2f, 56, Changnyong-Daero 256beon-Gil
Yeongtong-Gu
Suwon-Si,  KR
Applicant Contact Lee Jiyeon
Correspondent
Fims Co., Ltd.
2f, 56, Changnyong-Daero 256beon-Gil
Yeongtong-Gu
Suwon-Si,  KR
Correspondent Contact Lee Jiyeon
Regulation Number888.3080
Classification Product Code
ODP  
Date Received09/22/2025
Decision Date 07/23/2026
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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